Robotic Walking Device to Improve Mobility in Parkinson's Disease

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT03751371

Collaborator

Michael J. Fox Foundation for Parkinson's Research (Other), Honda Research and Development Americas, Inc (Other)

Enrollment

Location

Arms

28.5

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: Training with HWA device Other: Usual Care	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2019

Actual Primary Completion Date :

Sep 27, 2021

Actual Study Completion Date :

Sep 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Walking Training with the HWA Device Training with HWA device	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 Usual Care	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.

Arm

Intervention/Treatment

Experimental: Walking Training with the HWA Device

Training with HWA device

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

Usual Care

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.

Outcome Measures

Primary Outcome Measures

Gait Velocity [8 weeks]
Walking speed in meters per second

Secondary Outcome Measures

6-Minute Walk Test [8 weeks]
Distance walked in 6 minutes, reported in feet
Stride length [8 weeks]
Stride length in centimeters
Double support time [8 weeks]
Double support time in seconds
Swing time [8 weeks]
Swing time in seconds
Double support time coefficient of variability (ratio of the standard deviation to the mean) [8 weeks]
double support time standard deviation divided by the mean double support time
Swing time coefficient of variability (ratio of the standard deviation to the mean) [8 weeks]
swing time standard deviation divided by the mean swing time
Stride length coefficient of variability (ratio of the standard deviation to the mean) [8 weeks]
Stride length standard deviation divided by the mean stride length
Participants' Perceived Ease of Walking [8 weeks]
Indicated on a visual analog scale (100 mm 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.
Self-Efficacy for Measuring Chronic Disease 6-Item Scale [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.
Number of Steps [5 days during Weeks 1 and 8 of intervention]
Measured by accelerometers to quantitatively measure physical activity
Time Spent Walking [5 days during Weeks 1 and 8 of intervention]
Measured by accelerometers to quantitatively measure physical activity
Number of Falls [5 days during Weeks 1 and 8 of intervention]
Measured by accelerometers to quantitatively measure physical activity
Number of falls and adverse events [8 weeks]
Number of falls and other adverse events recorded in a diary during the 8-week intervention to measure safety
Freezing of Gait Questionnaire [8 weeks]
Questionnaire to measure severity of freezing of gait

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.