Trial Outcomes & Findings for Robotic Walking Device to Improve Mobility in Parkinson's Disease (NCT NCT03751371)

NCT ID: NCT03751371

Last Updated: 2023-06-18

Results Overview

Walking speed in meters per second

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2023-06-18

Participant Flow

Participant milestones

Measure	Walking Training With the HWA Device Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Overall Study STARTED	23	22
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Walking Training With the HWA Device n=23 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=22 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=23 Participants	5 Participants n=22 Participants	9 Participants n=45 Participants
Age, Categorical >=65 years	19 Participants n=23 Participants	17 Participants n=22 Participants	36 Participants n=45 Participants
Age, Continuous	72 years n=23 Participants	72 years n=22 Participants	72 years n=45 Participants
Sex: Female, Male Female	10 Participants n=23 Participants	2 Participants n=22 Participants	12 Participants n=45 Participants
Sex: Female, Male Male	13 Participants n=23 Participants	20 Participants n=22 Participants	33 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	23 participants n=23 Participants	22 participants n=22 Participants	45 participants n=45 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Missing gait velocity data for one participant in the Training group

Walking speed in meters per second

Outcome measures

Measure	Walking Training With the HWA Device n=19 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Gait Velocity	1.25 Meters per second Standard Deviation 0.30	1.25 Meters per second Standard Deviation 0.33

SECONDARY outcome

Timeframe: 8 weeks

Distance walked in 6 minutes, reported in meters

Outcome measures

Measure	Walking Training With the HWA Device n=20 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
6-Minute Walk Test	416.93 Meters Standard Deviation 124.35	426.92 Meters Standard Deviation 125.00

SECONDARY outcome

Timeframe: 8 weeks

Population: Missing data for one person in the training group

Stride length in centimeters

Outcome measures

Measure	Walking Training With the HWA Device n=19 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Stride Length	128.96 Centimeters Standard Deviation 25.53	131.79 Centimeters Standard Deviation 30.87

SECONDARY outcome

Timeframe: 8 weeks

Population: Missing data for one person in the training group

Double support time in seconds

Outcome measures

Measure	Walking Training With the HWA Device n=19 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Double Support Time	18.01 Seconds Standard Deviation 5.56	16.77 Seconds Standard Deviation 4.38

SECONDARY outcome

Timeframe: 8 weeks

Population: Missing data for one person in the training group

Swing time in seconds of right leg

Outcome measures

Measure	Walking Training With the HWA Device n=19 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Swing Time - Right Leg	41.28 Seconds Standard Deviation 2.93	41.94 Seconds Standard Deviation 2.37

SECONDARY outcome

Timeframe: 8 weeks

Population: Missing data for one person in the training group

Swing time in seconds of left leg

Outcome measures

Measure	Walking Training With the HWA Device n=19 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Swing Time - Left Leg	40.86 Seconds Standard Deviation 3.06	41.47 Seconds Standard Deviation 2.72

SECONDARY outcome

Timeframe: 8 weeks

Population: Missing data for one person in the training group

The double support time coefficient of variation was calculated by first calculating the mean and SD of the double support time for each of the participants. The calculation of the coefficient of variation were done by taking the standard deviations and dividing them by the mean. Thus calculation of the double support time coefficient of variation required multiple measures for each participant. After calculating the double support time coefficients of variation for each participant, we then calculated the mean and SD of the double support time coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.

Outcome measures

Measure	Walking Training With the HWA Device n=19 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Double Support Time Coefficient of Variation	0.20 Coefficient of variation Standard Deviation 0.09	0.23 Coefficient of variation Standard Deviation 0.17

SECONDARY outcome

Timeframe: 8 weeks

Population: Missing data for one person in the training group

The swing time coefficient of variation of right leg was calculated by first calculating the mean and SD of the swing time of the right leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of right leg coefficient of variation required multiple measures for each participant. After calculating the swing time of right leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the right leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.

Outcome measures

Measure	Walking Training With the HWA Device n=19 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Swing Time Coefficient of Variation of Right Leg	0.05 Coefficient of variation Standard Deviation 0.02	0.05 Coefficient of variation Standard Deviation 0.05

SECONDARY outcome

Timeframe: 8 weeks

Population: Missing data for one person in the training group

The swing time coefficient of variation of left leg was calculated by first calculating the mean and SD of the swing time of the left leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of left leg coefficient of variation required multiple measures for each participant. After calculating the swing time of left leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the left leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.

Outcome measures

Measure	Walking Training With the HWA Device n=19 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Swing Time Coefficient of Variation of Left Leg	0.05 Coefficient of variation Standard Deviation 0.02	0.06 Coefficient of variation Standard Deviation 0.05

SECONDARY outcome

Timeframe: 8 weeks

Population: Missing data for one person in the training group

The stride length coefficient of variation was calculated by first calculating the mean and SD of the stride length for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the stride length coefficient of variation required multiple measures for each participant. After calculating the stride length coefficients of variation for each participant, we then calculated the mean and SD of the stride length coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.

Outcome measures

Measure	Walking Training With the HWA Device n=19 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Stride Length Coefficient of Variation	0.07 Coefficient of variation Standard Deviation 0.04	0.08 Coefficient of variation Standard Deviation 0.08

SECONDARY outcome

Timeframe: 8 weeks

Indicated on a visual analog scale (line with demarcations of 0-10 spaced evenly and with anchors "Not at all easy" at 0 on the left end, moderately easy at 5, and "Extremely easy" at 10 on the right end). Participants are asked to rate where on line it indicates how easy it felt for them to walk during the six minute walk test.

Outcome measures

Measure	Walking Training With the HWA Device n=20 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Participants' Perceived Ease of Walking	6.05 units on a scale Standard Deviation 1.96	7.47 units on a scale Standard Deviation 2.04

SECONDARY outcome

Timeframe: 8 weeks

Questionnaire to measure participants' confidence (I.e., self-efficacy) in performing daily activities. The score for the scale is the mean of the 6 items with a range of possible scores from 1 to 10. Higher number (10) indicates higher self-efficacy.

Outcome measures

Measure	Walking Training With the HWA Device n=20 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Self-Efficacy for Measuring Chronic Disease 6-Item Scale	7.71 score on a scale Standard Deviation 1.50	8.00 score on a scale Standard Deviation 1.49

SECONDARY outcome

Timeframe: 8 weeks

The Freezing of Gait Questionnaire assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects. Six items are scored on 0-4 scale for a total score range of 0-24, with higher scores indicating worse outcomes.

Outcome measures

Measure	Walking Training With the HWA Device n=20 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Freezing of Gait Questionnaire	9.00 score on a scale Standard Deviation 6.49	9.85 score on a scale Standard Deviation 5.45

SECONDARY outcome

Timeframe: 8 weeks

Number of participants who recorded falls in a log during the 8-week intervention

Outcome measures

Measure	Walking Training With the HWA Device n=20 Participants Training with HWA device Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.	Usual Care n=20 Participants Usual Care Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Number of Participants With Falls	13 Participants	11 Participants

Adverse Events

Walking Training With the HWA Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Anne Kloos

The Ohio State University

Phone: 614-688-5942

Email: kloos.4@osu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place