Robotic Walking Device to Improve Mobility in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Use of a Robotic Walking Device to Improve Home and Community Mobility in People With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751371
• Other study ID #: 2018H0397
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: May 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Difficulties with walking in people with Parkinson's disease contribute to injurious falls and decreased quality of life. The Honda Walking Assist (HWA) robotic device is designed to assist individuals with gait impairments to take longer strides and walk faster. This study will investigate the impact of HWA usage on mobility in the home and community in individuals with PD. It will also examine feasibility and safety of HWA usage in the PD population. Specific Aim 1: Determine the short-term impact of mechanical gait assistance on efficiency and ease of walking in individuals with PD. With disease progression, individuals with PD develop gait impairments (e.g., slower gait velocity, shorter step lengths, increased step-to-step variability, and freezing of gait), that interfere with their abilities to perform daily living tasks and participate in work, home, and social activities and predispose them to falls. The investigators hypothesize that wearing the HWA device will improve gait efficiency, gait parameters, and perceived ease of walking in individuals with PD compared to unassisted walking over a one session period. Specific Aim 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. Angular sensors embedded in the HWA monitor the cadence, angular velocity, and degree of hip extension and flexion of the device user. When the user initiates walking, the HWA automatically adjusts leg movements to reach target walk ratios (step length/cadence) by increasing the amount of hip flexion and/or extension using power supplied by the device. Thus, the HWA applies continuous, step-by-step cueing to individuals with PD to take bigger and more symmetrical steps, thereby producing a faster and more efficient walking pattern. By wearing the HWA device over an extended period of time, individuals with PD will repetitively practice walking with a more "normal" gait pattern, possibly driving neuroplastic changes that will translate to improve unassisted walking. The investigators hypothesize that an 8-week intervention of HWA device usage will improve gait efficiency, gait parameters, perceived ease of walking, self-confidence, and daily physical activity in the home and community in individuals with PD with and without the use of the device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Other:
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	Honda Research and Development Americas, Inc, Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Velocity	Walking speed in meters per second	8 weeks
Secondary	6-Minute Walk Test	Distance walked in 6 minutes, reported in meters	8 weeks
Secondary	Stride Length	Stride length in centimeters	8 weeks
Secondary	Double Support Time	Double support time in seconds	8 weeks
Secondary	Swing Time - Right Leg	Swing time in seconds of right leg	8 weeks
Secondary	Swing Time - Left Leg	Swing time in seconds of left leg	8 weeks
Secondary	Double Support Time Coefficient of Variation	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.	8 weeks
Secondary	Swing Time Coefficient of Variation of Right Leg	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.	8 weeks
Secondary	Swing Time Coefficient of Variation of Left Leg	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.	8 weeks
Secondary	Stride Length Coefficient of Variation	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.	8 weeks
Secondary	Participants' Perceived Ease of Walking	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.	8 weeks
Secondary	Self-Efficacy for Measuring Chronic Disease 6-Item Scale	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.	8 weeks
Secondary	Freezing of Gait Questionnaire	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.	8 weeks
Secondary	Number of Participants With Falls	Number of participants who recorded falls in a log during the 8-week intervention	8 weeks