Trial Outcomes & Findings for Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease (NCT NCT05586490)

Last Updated: 2025-01-14

Results Overview

Completed at 2nd study visit after a 1-hour session using the device. UAQ part 1 assesses potential difficulties experienced while using the device. UAQ part 1 scores range from 0 to 90, with lower scores indicating fewer difficulties experienced.

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

After 1-hour session using the device

Results posted on

2025-01-14

Participant Flow

This study was originally intended to be completed as a sequence from Aim 1 to Aim 2, then to Aim 3. However, due to scheduling conflicts and attrition, subjects were invited to participate in individual aims to ensure sufficient data collection for each aim. Since some subjects completed multiple aims while others completed all aims, results were analyzed by aim, and thus are presented in that way here. In total, 38 participants were enrolled, with 1 withdrawal prior to randomization.

Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.

Participant milestones

Participant milestones
Measure	Participants Whose 1st Participation Was in Aim 1 Aim 1 consisted of 2-sessions of in-lab feasibility testing of research device in people with Parkinson disease(PwP)	Participants Whose First Participation Was in Aim 2 Aim 2 consists of 5-sessions of in-lab feasibility testing of research device in people with Parkinson disease(PwP) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP	Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Research Device Arm Participants of the in-home feasibility trial who were randomized into the research device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm	Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Alternate Device Arm Participants of the in-home feasibility trial who were randomized into the alternate device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP	Participants Whose 1st Participation Was in Aim 3: In-Home Testing - No Device Arm Participants of the in-home feasibility trial who were randomized into the no device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm
Completed Data Collection for Aim 1 STARTED	18	0	0	0	0
Completed Data Collection for Aim 1 COMPLETED	18	0	0	0	0
Completed Data Collection for Aim 1 NOT COMPLETED	0	0	0	0	0
Completed Data Collection for Aim 2 STARTED	4	4	0	0	0
Completed Data Collection for Aim 2 COMPLETED	4	4	0	0	0
Completed Data Collection for Aim 2 NOT COMPLETED	0	0	0	0	0
Completed Aim 3 - Research Device Arm STARTED	1	1	5	0	0
Completed Aim 3 - Research Device Arm COMPLETED	1	1	4	0	0
Completed Aim 3 - Research Device Arm NOT COMPLETED	0	0	1	0	0
Completed Aim 3 - Alternate Device Arm STARTED	2	0	0	5	0
Completed Aim 3 - Alternate Device Arm COMPLETED	1	0	0	5	0
Completed Aim 3 - Alternate Device Arm NOT COMPLETED	1	0	0	0	0
Completed Aim 3 - No Device Arm STARTED	2	0	0	0	5
Completed Aim 3 - No Device Arm COMPLETED	1	0	0	0	5
Completed Aim 3 - No Device Arm NOT COMPLETED	1	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Whose 1st Participation Was in Aim 1 Aim 1 consisted of 2-sessions of in-lab feasibility testing of research device in people with Parkinson disease(PwP)	Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Research Device Arm Participants of the in-home feasibility trial who were randomized into the research device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm
Completed Aim 3 - Research Device Arm Withdrawal by Subject	0	1
Completed Aim 3 - Alternate Device Arm Withdrawal by Subject	1	0
Completed Aim 3 - No Device Arm Withdrawal by Subject	1	0

Baseline Characteristics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Whose 1st Participation Was in Aim 1 n=18 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions.	Participants Whose First Participation Was in Aim 2 n=8 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 5 lab sessions.	Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Research Device Arm n=7 Participants Participants of the in-home feasibility trial who were randomized into the research device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm.	Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Alternate Device Arm n=7 Participants Participants of the in-home feasibility trial who were randomized into the alternate device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm.	Participants Whose 1st Participation Was in Aim 3: In-Home Testing - No Device Arm n=7 Participants Participants of the in-home feasibility trial who were randomized into the no device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm.	Total n=47 Participants Total of all reporting groups
Age, Continuous Completed Data Collection for Aim 1	71.23 years STANDARD_DEVIATION 7.94 • n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	71.23 years STANDARD_DEVIATION 7.94 • n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Age, Continuous Completed Data Collection for Aim 2	68 years STANDARD_DEVIATION 11.8 • n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	70.75 years STANDARD_DEVIATION 6.90 • n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	69.38 years STANDARD_DEVIATION 9.07 • n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Age, Continuous Completed Data Collection for Aim 3	71.8 years STANDARD_DEVIATION 3.27 • n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	68 years STANDARD_DEVIATION 0 • n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	65.2 years STANDARD_DEVIATION 4.87 • n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	68.6 years STANDARD_DEVIATION 5.68 • n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	67.6 years STANDARD_DEVIATION 5.90 • n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	68.29 years STANDARD_DEVIATION 5.09 • n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Sex: Female, Male Completed Data Collection for Aim 1 · Female	4 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	4 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Sex: Female, Male Completed Data Collection for Aim 1 · Male	14 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	14 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Sex: Female, Male Completed Data Collection for Aim 2 · Female	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	2 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	2 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Sex: Female, Male Completed Data Collection for Aim 2 · Male	4 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	2 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	6 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Sex: Female, Male Completed Data Collection for Aim 3 · Female	2 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	1 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	1 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	3 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	2 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	9 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Sex: Female, Male Completed Data Collection for Aim 3 · Male	3 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	4 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	2 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	3 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	12 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Ethnicity (NIH/OMB) Completed Data Collection for Aim 1 · Hispanic or Latino	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Ethnicity (NIH/OMB) Completed Data Collection for Aim 1 · Not Hispanic or Latino	18 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	18 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Ethnicity (NIH/OMB) Completed Data Collection for Aim 1 · Unknown or Not Reported	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Ethnicity (NIH/OMB) Completed Data Collection for Aim 2 · Hispanic or Latino	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	0 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Ethnicity (NIH/OMB) Completed Data Collection for Aim 2 · Not Hispanic or Latino	4 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	4 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	8 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Ethnicity (NIH/OMB) Completed Data Collection for Aim 2 · Unknown or Not Reported	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	0 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Ethnicity (NIH/OMB) Completed Data Collection for Aim 3 · Hispanic or Latino	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Ethnicity (NIH/OMB) Completed Data Collection for Aim 3 · Not Hispanic or Latino	5 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	1 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	5 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	5 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	5 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	21 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Ethnicity (NIH/OMB) Completed Data Collection for Aim 3 · Unknown or Not Reported	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 1 · American Indian or Alaska Native	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 1 · Asian	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 1 · Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 1 · Black or African American	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 1 · White	18 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	18 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 1 · More than one race	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 1 · Unknown or Not Reported	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	—	0 Participants n=18 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 2 · American Indian or Alaska Native	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	0 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 2 · Asian	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	0 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 2 · Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	0 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 2 · Black or African American	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	0 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 2 · White	4 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	4 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	8 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 2 · More than one race	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	0 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 2 · Unknown or Not Reported	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=4 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	—	—	—	0 Participants n=8 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 3 · American Indian or Alaska Native	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 3 · Asian	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 3 · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 3 · Black or African American	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 3 · White	5 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	1 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	5 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	5 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	5 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	21 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 3 · More than one race	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Race (NIH/OMB) Completed Data Collection for Aim 3 · Unknown or Not Reported	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=1 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=5 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.	0 Participants n=21 Participants • Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Region of Enrollment United States	18 Participants n=18 Participants • Some participants were recruited to participate in more than one aim of the study. "Overall Number of Baseline Participants" represents the total number of individuals enrolled in each arm. The number analyzed here represents the total number of participants whose FIRST participation was in each respective arm.	4 Participants n=4 Participants • Some participants were recruited to participate in more than one aim of the study. "Overall Number of Baseline Participants" represents the total number of individuals enrolled in each arm. The number analyzed here represents the total number of participants whose FIRST participation was in each respective arm.	5 Participants n=5 Participants • Some participants were recruited to participate in more than one aim of the study. "Overall Number of Baseline Participants" represents the total number of individuals enrolled in each arm. The number analyzed here represents the total number of participants whose FIRST participation was in each respective arm.	5 Participants n=5 Participants • Some participants were recruited to participate in more than one aim of the study. "Overall Number of Baseline Participants" represents the total number of individuals enrolled in each arm. The number analyzed here represents the total number of participants whose FIRST participation was in each respective arm.	5 Participants n=5 Participants • Some participants were recruited to participate in more than one aim of the study. "Overall Number of Baseline Participants" represents the total number of individuals enrolled in each arm. The number analyzed here represents the total number of participants whose FIRST participation was in each respective arm.	37 Participants n=37 Participants • Some participants were recruited to participate in more than one aim of the study. "Overall Number of Baseline Participants" represents the total number of individuals enrolled in each arm. The number analyzed here represents the total number of participants whose FIRST participation was in each respective arm.
(Aim 3) Mean time to complete the Timed Up and Go test (TUG)	—	—	7.65 seconds STANDARD_DEVIATION 1.68 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	7.49 seconds STANDARD_DEVIATION 1.12 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	8.53 seconds STANDARD_DEVIATION 1.94 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	7.89 seconds STANDARD_DEVIATION 1.58 • n=18 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.
(Aim 3) Mean time to complete the Instrumented Stand up and Walk Test (iSAW)	—	—	13.05 seconds STANDARD_DEVIATION 1.42 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	12.75 seconds STANDARD_DEVIATION 1.81 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	13.32 seconds STANDARD_DEVIATION 2.02 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	13.03 seconds STANDARD_DEVIATION 1.75 • n=18 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.
(Aim 3) Sensory postural control domain as measured during the MiniBESTest.	—	—	5.00 units on a scale STANDARD_DEVIATION 1.00 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	5.17 units on a scale STANDARD_DEVIATION 0.37 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	4.33 units on a scale STANDARD_DEVIATION 1.97 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	4.83 units on a scale STANDARD_DEVIATION 1.11 • n=18 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.
(Aim 3) Mean Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score	—	—	37.58 units on a scale STANDARD_DEVIATION 14.61 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	33 units on a scale STANDARD_DEVIATION 12.06 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	32.25 units on a scale STANDARD_DEVIATION 10.55 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	34.28 units on a scale STANDARD_DEVIATION 12.41 • n=18 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.
(Aim 3) Mean Modified Hoehn and Yahr stage	—	—	2.17 units on a scale STANDARD_DEVIATION 0.41 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	1.92 units on a scale STANDARD_DEVIATION 0.53 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	2.17 units on a scale STANDARD_DEVIATION 0.61 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	2.09 units on a scale STANDARD_DEVIATION 0.53 • n=18 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.
(Aim 3) Mean response time during the Stroop Stepping Test	—	—	2.10 seconds STANDARD_DEVIATION 0.42 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	1.92 seconds STANDARD_DEVIATION 0.34 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	1.99 seconds STANDARD_DEVIATION 0.15 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	2.00 seconds STANDARD_DEVIATION 0.30 • n=18 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.
(Aim 3) Mean time taken to complete Stroop Color Word Interference Test	—	—	162.25 seconds STANDARD_DEVIATION 62.74 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	168.82 seconds STANDARD_DEVIATION 77.46 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	167.76 seconds STANDARD_DEVIATION 30.60 • n=6 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.	166.28 seconds STANDARD_DEVIATION 56.93 • n=18 Participants • Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in.

PRIMARY outcome

Timeframe: After 1-hour session using the device

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=18 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores	7.28 score on a scale Standard Deviation 6.18	—	—

PRIMARY outcome

Timeframe: After 1-hour session using the device

Completed at 2nd study visit after a 1-hour session using the device. UAQ part 2 assesses participant preferences for using the device. UAQ part 2 scores range from 0 to 30, with higher scores indicating greater personal preference for using the device.

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=18 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 2 Total Scores	23.72 score on a scale Standard Deviation 5.12	—	—

PRIMARY outcome

Timeframe: After 1-hour session using the device

Completed at 2nd study visit after a 1-hour session using the device. SUS is a questionnaire consisting of 10 Likert-scale questions to assess usability of the device. Benchmarked scores range from 0 to 100, with higher scores indicating better usability of the device.

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=18 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 1) Mean System Usability Scale (SUS) Total Scores	83.19 score on a scale Standard Deviation 14.09	—	—

PRIMARY outcome

Timeframe: After 2-week intervention

Mobility test that evaluates the amount of time it takes the participants to stand, walk 10 feet, turn around, walk, and sit back down. Improved performance is indicated by lower time to complete measured in seconds.

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=8 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) Pre-Intervention	18.761 seconds Standard Deviation 5.651	—	—
(Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) Post-Intervention	18.124 seconds Standard Deviation 4.700	—	—

PRIMARY outcome

Timeframe: After 2-week intervention

Population: Although in participant flow, the 8 participants are divided by what arm they subsequently participated in, within this outcome measure, there is no logical reason to separate them, as they were all testing the same device used in the same manner.

Balance test that evaluates how long participants are able to stand on a foam pillow before losing balance. Improved performance is indicated by longer balance duration.

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=8 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 2) Change in Mean Duration of Balance During Romberg Test Condition Pre-Intervention	26.25 seconds Standard Deviation 10.61	—	—
(Aim 2) Change in Mean Duration of Balance During Romberg Test Condition Post-Intervention	30 seconds Standard Deviation 0	—	—

PRIMARY outcome

Timeframe: After 2-week intervention

During this test, subjects make steps based on congruent (stimulus prompts the stepping response) and incongruent (stimulus prompts inhibition of the stepping response) arrows and sounds. This will be used to compare the mean response time for stepping from pre and post intervention visits to determine if reaction time improves (indicated by a decrease in response time). Mean times include responses to both congruent and incongruent stimuli.

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=8 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 2) Change in Mean Response Time During the Stroop Stepping Test Pre-Intervention	1.887 seconds Standard Deviation 0.27	—	—
(Aim 2) Change in Mean Response Time During the Stroop Stepping Test Post-Intervention	1.874 seconds Standard Deviation 0.42	—	—

PRIMARY outcome

Timeframe: After 2-week intervention

During this test, participants read congruent and incongruent colored names of colors. This will be used to compare the number of incorrect responses and the time it takes to complete the test from pre and post intervention visits to determine if inhibitory control improves (indicated by decrease of incorrect responses and completion time).

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=8 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test Pre-Intervention	167.51 seconds Standard Deviation 55.96	—	—
(Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test Post-Intervention	152.71 seconds Standard Deviation 54.54	—	—

PRIMARY outcome

Timeframe: After 14-week intervention

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=6 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 3) Difference in Effect of Study Intervention on Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) in Study Device Group Versus Control Groups. Pre-Intervention	7.65 seconds Standard Deviation 1.68	7.49 seconds Standard Deviation 1.12	8.53 seconds Standard Deviation 1.94
(Aim 3) Difference in Effect of Study Intervention on Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) in Study Device Group Versus Control Groups. Post-Intervention	8.27 seconds Standard Deviation 1.77	6.83 seconds Standard Deviation 1.42	8.47 seconds Standard Deviation 2.34

PRIMARY outcome

Timeframe: After 14-week intervention

Mobility test that evaluates the amount of time it takes the participant to walk 10 feet, make a turn around a cone, and return to the starting position. Improved performance is indicated by lower time to complete measured in seconds.

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=6 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 3) Difference in Effect of Intervention on Mean Time to Complete the Instrumented Stand and Walk Test (iSAW) in Study Device Group Versus Control Groups. Pre-Intervention	13.05 seconds Standard Deviation 1.42	12.72 seconds Standard Deviation 1.81	13.32 seconds Standard Deviation 2.02
(Aim 3) Difference in Effect of Intervention on Mean Time to Complete the Instrumented Stand and Walk Test (iSAW) in Study Device Group Versus Control Groups. Post-Intervention	12.40 seconds Standard Deviation 1.76	11.35 seconds Standard Deviation 1.99	11.92 seconds Standard Deviation 2.21

PRIMARY outcome

Timeframe: After 14-week intervention

Balance test that evaluates how long participants are able to stand on surfaces of varying firmness with eyes open and closed. Domain scores range from 0 to 6 with higher scores indicating stronger sensory postural control.

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=6 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. Pre-Intervention	5.00 units on a scale Standard Deviation 1.00	5.17 units on a scale Standard Deviation 0.37	4.33 units on a scale Standard Deviation 1.97
(Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. Post-Intervention	3.83 units on a scale Standard Deviation 1.46	4.5 units on a scale Standard Deviation 1.71	3.33 units on a scale Standard Deviation 1.60

PRIMARY outcome

Timeframe: After 14-week intervention

Movement Disorder Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS part III) is the motor examination portion of the UPDRS evaluation. Scores range from 0-132, with higher scores indicating greater severity of motor symptoms.

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=6 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 3) Difference in Effect of Intervention on Mean Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score in Study Device Group Versus Control Groups. Pre-Intervention	37.58 score on a scale Standard Deviation 14.61	33 score on a scale Standard Deviation 12.06	32.25 score on a scale Standard Deviation 10.55
(Aim 3) Difference in Effect of Intervention on Mean Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score in Study Device Group Versus Control Groups. Post-Intervention	36.83 score on a scale Standard Deviation 12.91	27.67 score on a scale Standard Deviation 8.86	36.58 score on a scale Standard Deviation 9.55

PRIMARY outcome

Timeframe: At baseline (descriptive statistic)

The Hoehn and Yahr scale is a widely used clinical rating scale to categorize the progression of Parkinson's disease into stages ranging no disease (0) to wheelchair bound (5).

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=6 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline	2.17 score on a scale Standard Deviation 0.41	1.92 score on a scale Standard Deviation 0.58	2.17 score on a scale Standard Deviation 0.61

PRIMARY outcome

Timeframe: After 14-week intervention

During this test, subjects make steps based on congruent (stimulus prompts the stepping response) and incongruent (stimulus prompts inhibition of the stepping response) arrows and sounds. These responses are combined to compare the response time for stepping from pre and post intervention visits to determine if reaction time improves (indicated by a decrease in response time). Mean times include responses to both congruent and incongruent stimuli.

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=6 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. Pre-Intervention	2.10 seconds Standard Deviation 0.42	1.92 seconds Standard Deviation 0.34	1.99 seconds Standard Deviation 0.15
(Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. Post-Intervention	1.92 seconds Standard Deviation 0.50	1.83 seconds Standard Deviation 0.33	1.97 seconds Standard Deviation 0.33

PRIMARY outcome

Timeframe: After 14-week intervention

Outcome measures

Outcome measures
Measure	In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) n=6 Participants Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP for human user acceptance testing for 2 lab sessions (aim 1)	In-home Feasibility Testing (Alternate Device) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension. Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP existing standard rehabilitation device: existing standard rehabilitation device to be used for in-home comparison testing for aim 3	In-home Feasibility Testing (no Device in at Home Portion) n=6 Participants Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
(Aim 3) Difference in Effect of Study Device Intervention on Time Taken to Complete Stroop Color Word Interference Test in Study Device Group Versus Control Groups. Pre-Intervention	162.25 seconds Standard Deviation 62.74	168.82 seconds Standard Deviation 77.46	167.76 seconds Standard Deviation 30.60
(Aim 3) Difference in Effect of Study Device Intervention on Time Taken to Complete Stroop Color Word Interference Test in Study Device Group Versus Control Groups. Post-Intervention	158.53 seconds Standard Deviation 63.42	163.19 seconds Standard Deviation 72.97	153.95 seconds Standard Deviation 20.57

Adverse Events

Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aim 3: In-home Feasibility Testing - Research Device Arm

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Aim 3: In-home Feasibility Testing - Alternate Device Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Aim 3: In-home Feasibility Testing - No Device Arm

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) n=18 participants at risk Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions.	Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) n=8 participants at risk Multifunctional rehabilitation device for PwP for human user acceptance testing for 5 lab sessions.	Aim 3: In-home Feasibility Testing - Research Device Arm n=7 participants at risk Participants of the in-home feasibility trial who were randomized into the research device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm.	Aim 3: In-home Feasibility Testing - Alternate Device Arm n=7 participants at risk Participants of the in-home feasibility trial who were randomized into the alternate device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm	Aim 3: In-home Feasibility Testing - No Device Arm n=7 participants at risk Participants of the in-home feasibility trial who were randomized into the no device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm.
Vascular disorders Transient ischemic attack (TIA)	0.00% 0/18 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/8 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	14.3% 1/7 • Number of events 1 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.

Other adverse events

Other adverse events
Measure	Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) n=18 participants at risk Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions.	Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) n=8 participants at risk Multifunctional rehabilitation device for PwP for human user acceptance testing for 5 lab sessions.	Aim 3: In-home Feasibility Testing - Research Device Arm n=7 participants at risk Participants of the in-home feasibility trial who were randomized into the research device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm.	Aim 3: In-home Feasibility Testing - Alternate Device Arm n=7 participants at risk Participants of the in-home feasibility trial who were randomized into the alternate device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm	Aim 3: In-home Feasibility Testing - No Device Arm n=7 participants at risk Participants of the in-home feasibility trial who were randomized into the no device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm.
Musculoskeletal and connective tissue disorders Fatigue	5.6% 1/18 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/8 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	0.00% 0/18 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/8 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	42.9% 3/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	28.6% 2/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	28.6% 2/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.
Cardiac disorders Dizziness	0.00% 0/18 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/8 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	28.6% 2/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	14.3% 1/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.
General disorders Intercurrent Illness	0.00% 0/18 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/8 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	14.3% 1/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	28.6% 2/7 • Number of events 3 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	14.3% 1/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.
Injury, poisoning and procedural complications Fall	0.00% 0/18 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/8 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	14.3% 1/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	14.3% 1/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.
Eye disorders Eye Strain	0.00% 0/18 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/8 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	14.3% 1/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.	0.00% 0/7 • For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2. Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.

Additional Information

Chatkaew Pongmala, PhD

University of Michigan

Phone: 734-936-1168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place