Robotic Walking Device to Improve Mobility in Parkinson's Disease

NCT ID: NCT03751371

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2021-09-27

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Walking Training with the HWA Device

Training with HWA device

Group Type: EXPERIMENTAL

Training with HWA device

Intervention Type: 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.

Usual Care

Usual Care

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

Honda Research and Development Americas

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Anne Kloos

Professor-Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Kloos

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Deb Kegelmeyer

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

Reference Type: DERIVED

PMID: 38588457 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Reference Type: DERIVED

PMID: 36602886 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2018H0397

Identifier Type: -

Identifier Source: org_study_id