Robotic Walking Device to Improve Mobility in Parkinson's Disease

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.

Conditions

• Parkinson Disease

Interventions

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.

Sponsors & Collaborators

• Michael J. Fox Foundation for Parkinson's Research

  collaborator OTHER

• Honda Research and Development Americas

  collaborator INDUSTRY

• Ohio State University

  lead OTHER

Principal Investigators

• Anne Kloos · Ohio State University

• Deb Kegelmeyer · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-15

Primary Completion

2021-09-27

Completion

2021-09-27

FDA Device

Yes

Countries

• United States

Study Locations