Clinical trial NCT03751371: Robotic Walking Device to Improve Mobility in Parkinson's Disease
Official title: Use of a Robotic Walking Device to Improve Home and Community Mobility in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
Exoskeleton
Honda
Walking Assist
Walking
Gait
Mobility
Rehabilitation
Physical Therapy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
name: Honda Research and Development Americas
First posted: 2018-11-23
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Gait Velocity
timeFrame: 8 weeks
Secondary outcomes:
measure: 6-Minute Walk Test
timeFrame: 8 weeks
measure: Stride Length
timeFrame: 8 weeks
measure: Double Support Time
timeFrame: 8 weeks
measure: Swing Time - Right Leg
timeFrame: 8 weeks
measure: Swing Time - Left Leg
timeFrame: 8 weeks
measure: Double Support Time Coefficient of Variation
timeFrame: 8 weeks
measure: Swing Time Coefficient of Variation of Right Leg
timeFrame: 8 weeks
measure: Swing Time Coefficient of Variation of Left Leg
timeFrame: 8 weeks
measure: Stride Length Coefficient of Variation
timeFrame: 8 weeks
measure: Participants' Perceived Ease of Walking
timeFrame: 8 weeks
measure: Self-Efficacy for Measuring Chronic Disease 6-Item Scale
timeFrame: 8 weeks
measure: Freezing of Gait Questionnaire
timeFrame: 8 weeks
measure: Number of Participants With Falls
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Anne Kloos
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Deb Kegelmeyer
role: PRINCIPAL_INVESTIGATOR
References: