Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease

NCT ID: NCT04587193

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2023-01-02

Brief Summary

The purpose of this study is to test the safety and efficacy of using of a portable exoskeleton for walking training in persons with Parkinson's disease that have gait mobility problems and/or postural instability.

Detailed Description

This is a feasibility study to examine a novel application of state-of-the-art robotic-assist gait training to improve mobility in people with Parkinson's disease (PD). The study will investigate the utility of the Keeogo® exoskeleton (a robotic-assist gait training device) for people with PD. The Keeogo® offers advantages of being lightweight and portable (for eventual home use) and is relatively quick to attach and remove. The aims here are to establish the safety of the Keeogo® for gait training in persons with PD and to preliminarily assess the potential efficacy of the Keeogo® for better balance control, gait mobility and fall reduction in persons with PD.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PD participants

Subjects will participate in a total of 10 walking sessions, twice per week for 5 weeks, while wearing a robotic-assist gait training device. There will also be 3 additional visits for assessments at: baseline (up to 1 prior to treatment), post (1 week after last treatment), and final (4-6 weeks after last treatment).

Group Type: EXPERIMENTAL

Robotic-assist gait training device

Intervention Type: DEVICE

PD participants will walk while wearing a robotic-assist gait training device

Interventions

Robotic-assist gait training device

PD participants will walk while wearing a robotic-assist gait training device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Parkinson's Participant

1. age 21 years or older,

2. PD confirmed by a movement disorder specialist using UK Brain Bank Criteria,

3. H&Y stage II, III, IV, or V.

Caregiver participant

1. Caregiver of PD participant and is willing to complete questionnaire

2. moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30) except in cases where the clinician and the participants Legally Authorized Representative both determine the participant can safely complete the study

Exclusion Criteria

Parkinson's Participant

1. neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of gait, stance, balance or coordination,

2. history of implantable cardiac device or ablative surgery,

3. moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30),

4. uncontrolled orthostatic hypotension,

5. feeding tube or associated port placement (PEG/J-PEG),

6. body height less than 5'1" or greater than 6'3" and

7. body weight greater than 250 pounds.

Caregiver participant

1) Unwilling to complete questionnaire

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Baron, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University Health System

Robert Hand, PT, DPT

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University Health System

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

HM20020066

Identifier Type: -

Identifier Source: org_study_id