NCT03751371

Robotic Walking Device to Improve Mobility in Parkinson's Disease

Completed NA Results posted Last updated 18 June 2023

What this trial tests

NA trial testing Training with HWA device in Parkinson Disease in 45 participants. Completed in 27 September 2021.

Timeline

15 May 2019

Primary endpoint
27 September 2021

27 September 2021

Quick facts

Lead sponsor	Ohio State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	45
Start date	15 May 2019
Primary completion	27 September 2021
Estimated completion	27 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Training with HWA device
• Usual Care

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Ohio State University

Who can join

Adults 50 to 80, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Gait Velocity Primary · 8 weeks

Walking speed in meters per second

Group	Value	95% CI
Walking Training With the HWA Device	1.25	± 0.30
Usual Care	1.25	± 0.33

6-Minute Walk Test Secondary · 8 weeks

Distance walked in 6 minutes, reported in meters

Group	Value	95% CI
Walking Training With the HWA Device	416.93	± 124.35
Usual Care	426.92	± 125.00

Stride Length Secondary · 8 weeks

Stride length in centimeters

Group	Value	95% CI
Walking Training With the HWA Device	128.96	± 25.53
Usual Care	131.79	± 30.87

Double Support Time Secondary · 8 weeks

Double support time in seconds

Group	Value	95% CI
Walking Training With the HWA Device	18.01	± 5.56
Usual Care	16.77	± 4.38

Swing Time - Right Leg Secondary · 8 weeks

Swing time in seconds of right leg

Group	Value	95% CI
Walking Training With the HWA Device	41.28	± 2.93
Usual Care	41.94	± 2.37

Swing Time - Left Leg Secondary · 8 weeks

Swing time in seconds of left leg

Group	Value	95% CI
Walking Training With the HWA Device	40.86	± 3.06
Usual Care	41.47	± 2.72

Double Support Time Coefficient of Variation Secondary · 8 weeks

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

Group	Value	95% CI
Walking Training With the HWA Device	0.20	± 0.09
Usual Care	0.23	± 0.17

Swing Time Coefficient of Variation of Right Leg Secondary · 8 weeks

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 vari

Group	Value	95% CI
Walking Training With the HWA Device	0.05	± 0.02
Usual Care	0.05	± 0.05

Swing Time Coefficient of Variation of Left Leg Secondary · 8 weeks

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

Group	Value	95% CI
Walking Training With the HWA Device	0.05	± 0.02
Usual Care	0.06	± 0.05

Stride Length Coefficient of Variation Secondary · 8 weeks

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 ce

Group	Value	95% CI
Walking Training With the HWA Device	0.07	± 0.04
Usual Care	0.08	± 0.08

Participants' Perceived Ease of Walking Secondary · 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.

Group	Value	95% CI
Walking Training With the HWA Device	6.05	± 1.96
Usual Care	7.47	± 2.04

Self-Efficacy for Measuring Chronic Disease 6-Item Scale Secondary · 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.

Group	Value	95% CI
Walking Training With the HWA Device	7.71	± 1.50
Usual Care	8.00	± 1.49

Sponsor's own description

This Phase II randomized controlled trial proposes to examine the impact of long-term use of a novel light-weight and wearable assistive robotic device, called the Honda Walking Assist (HWA) device, to improve mobility in the home and community in individuals with mild to moderate Parkinson's disease (PD). Specific aims of the project are to: 1) determine the short-term impact of mechanical gait assistance on efficiency and ease of walking in individuals with PD, and 2) determine the effect of long-term HWA device usage on the ease and ability to walk unassisted in the home and community in individuals with PD.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
   Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2023 · cited 110× · PMID 36602886 · DOI 10.1002/14651858.cd013856.pub2
2. Interventions for preventing falls in Parkinson's disease.
   Allen NE, Canning CG, Almeida LRS, Bloem BR, et al · · 2022 · cited 50× · PMID 35665915 · DOI 10.1002/14651858.cd011574.pub2
3. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
   Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2024 · cited 37× · PMID 38588457 · DOI 10.1002/14651858.cd013856.pub3