N/A
Completed N=45
Robotic Walking Device to Improve Mobility in Parkinson's Disease
Source: ClinicalTrials.gov NCT03751371 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Gait Velocity — 1.25; 1.25 Meters per second
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gait Velocity |
1.25; 1.25 | — |
| SECONDARY 6-Minute Walk Test |
416.93; 426.92 | — |
| SECONDARY Stride Length |
128.96; 131.79 | — |
| SECONDARY Double Support Time |
18.01; 16.77 | — |
| SECONDARY Swing Time - Right Leg |
41.28; 41.94 | — |
| SECONDARY Swing Time - Left Leg |
40.86; 41.47 | — |
| SECONDARY Double Support Time Coefficient of Variation |
0.20; 0.23 | — |
| SECONDARY Swing Time Coefficient of Variation of Right Leg |
0.05; 0.05 | — |
| SECONDARY Swing Time Coefficient of Variation of Left Leg |
0.05; 0.06 | — |
| SECONDARY Stride Length Coefficient of Variation |
0.07; 0.08 | — |
| SECONDARY Participants' Perceived Ease of Walking |
6.05; 7.47 | — |
| SECONDARY Self-Efficacy for Measuring Chronic Disease 6-Item Scale |
7.71; 8.00 | — |
| SECONDARY Freezing of Gait Questionnaire |
9.00; 9.85 | — |
| SECONDARY Number of Participants With Falls |
13; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of idiopathic Parkinson's disease
- Age 50-80 years
- Able to ambulate without assistance (Hoehn & Yahr stages 1-3)
- On stable doses of Parkinson's medications for at least 4 weeks prior to the study.
Exclusion Criteria
- Presence of other significant cardiac, neurological or orthopedic problems that affect gait
- Weight more than 220 pounds and height greater than 6'8"
- Electronic medical devices embedded in the body
- Participating in any physical therapy
- Inability to understand instructions required by the study.
Data sourced from ClinicalTrials.gov (NCT03751371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.