Trial Outcomes & Findings for RehabTouch Home Therapy for Stroke Patients (NCT NCT03503617)

Last Updated: 2022-02-07

Results Overview

The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

From Baseline to One-month Post-therapy

Results posted on

2022-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	RehabTouch Exercise Program Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional Tabletop Exercise Program Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Overall Study STARTED	14	13
Overall Study COMPLETED	14	10
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RehabTouch Home Therapy for Stroke Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RehabTouch Exercise Program n=14 Participants Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional Tabletop Exercise Program n=13 Participants Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises	Total n=27 Participants Total of all reporting groups
Age, Continuous	50 Years STANDARD_DEVIATION 11 • n=5 Participants	52 Years STANDARD_DEVIATION 9 • n=7 Participants	52 Years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to One-month Post-therapy

Population: Three participants in the conventional therapy group did not perform their one-month follow-up assessment; one of these did perform the end-of-therapy assessment. For this one participant, the missing one-month follow-up data point was imputed for the primary outcome measure by adding the average change in Fugl-Meyer score across all participants in the conventional therapy group from end-of-therapy to one-month follow-up to this participant's end-of-therapy Fugl-Meyer score.

Outcome measures

Outcome measures
Measure	RehabTouch Exercise Program n=14 Participants Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional Tabletop Exercise Program n=11 Participants Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy	8.0 Score on a Scale Standard Deviation 4.6	3.1 Score on a Scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: From Baseline to One-month Post-therapy

The Box \& Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.

Outcome measures

Outcome measures
Measure	RehabTouch Exercise Program n=14 Participants Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional Tabletop Exercise Program n=10 Participants Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Change in Box and Blocks Test Score	31.1 Boxes Standard Deviation 20.2	27.1 Boxes Standard Deviation 16.9

SECONDARY outcome

Timeframe: From Baseline to One-month Post-therapy

The 10MWT assesses walking speed in meters per second over a short duration.

Outcome measures

Outcome measures
Measure	RehabTouch Exercise Program n=14 Participants Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional Tabletop Exercise Program n=10 Participants Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
10 Meter Walk Test	1.06 meters per second Standard Deviation 0.41	1.07 meters per second Standard Deviation 0.39

SECONDARY outcome

Timeframe: One-month Post-therapy

The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity.

Outcome measures

Outcome measures
Measure	RehabTouch Exercise Program n=14 Participants Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional Tabletop Exercise Program n=10 Participants Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Motor Activity Log Amount of Use	3.11 Score on a Scale Standard Deviation 1.14	2.72 Score on a Scale Standard Deviation 1.65
Motor Activity Log How Well	3.01 Score on a Scale Standard Deviation 1.26	2.50 Score on a Scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: From Baseline to One-month Post-therapy

A standard analog scale that ranges from 0 to 10 for assessing pain.

Outcome measures

Outcome measures
Measure	RehabTouch Exercise Program n=14 Participants Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional Tabletop Exercise Program n=10 Participants Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Visual Analog Pain Scale	2.5 Score on a Scale Standard Deviation 2.3	4.6 Score on a Scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: From Baseline to One-month Post-therapy

The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement.

Outcome measures

Outcome measures
Measure	RehabTouch Exercise Program n=14 Participants Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. RehabTouch: Exercise using the motion sensing devices and a computer	Conventional Tabletop Exercise Program n=10 Participants Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Conventional tabletop exercise program: Exercise following printed sheets of exercises
Modified Ashworth Spasticity Scale Extension	0.42 Score on a Scale Standard Deviation 0.7	0.63 Score on a Scale Standard Deviation 0.92
Modified Ashworth Spasticity Scale Flexion	2.5 Score on a Scale Standard Deviation 2.1	2.1 Score on a Scale Standard Deviation 2.3

Adverse Events

RehabTouch Exercise Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Tabletop Exercise Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Zondervan

Flint Rehabilitation Devices

Phone: 9493137322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place