Robotic Walking Device to Improve Mobility in Parkinson's Disease

NCT03751371 | Completed Results FDA Device

• 1 other identifier: 2018H0397
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson; Exoskeleton; Honda; Walking Assist; Walking; Gait; Mobility; Rehabilitation; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Gait Velocity

  Walking speed in meters per second

  8 weeks

Secondary Outcomes (13)

• 6-Minute Walk Test

  8 weeks

• Stride Length

  8 weeks

• Double Support Time

  8 weeks

• Swing Time - Right Leg

  8 weeks

• Swing Time - Left Leg

  8 weeks

Study Arms (2)

Walking Training with the HWA Device

EXPERIMENTAL

Training with HWA device

Device: Training with HWA device

Usual Care

OTHER

Usual Care

Other: Usual Care

Interventions

Training with HWA device 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.

Walking Training with the HWA Device

Usual Care 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.

Usual Care

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• Honda Research and Development Americas: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• 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.

  PMID: 38588457 DERIVED

• 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.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Anne Kloos
• Organization: The Ohio State University

kloos.4@osu.edu

614-688-5942

Study Officials

• Anne Kloos

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Deb Kegelmeyer

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Clinical

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 23, 2018
• Study Start: May 15, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: June 18, 2023
• Results First Posted: June 18, 2023

Record last verified: 2023-05

Locations

US (1)