Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Safety of the Portable Exoskeleton
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Parkinson's Participant
- •age 21 years or older,
- •PD confirmed by a movement disorder specialist using UK Brain Bank Criteria,
- •H\&Y stage II, III, IV, or V.
- •Caregiver participant
- •Caregiver of PD participant and is willing to complete questionnaire
- •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
- •neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of gait, stance, balance or coordination,
- •history of implantable cardiac device or ablative surgery,
- •moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment \< 17/30),
- •uncontrolled orthostatic hypotension,
- •feeding tube or associated port placement (PEG/J-PEG),
- •body height less than 5'1" or greater than 6'3" and
- •body weight greater than 250 pounds.
- •Caregiver participant
- •Unwilling to complete questionnaire
Outcomes
Primary Outcomes
Safety of the Portable Exoskeleton
Time Frame: At the end of treatment (5 weeks)
Number of "prevented" or "near falls" requiring physical assistance by the investigative training team experienced by the participant during throughout the training.
Secondary Outcomes
- Change in Walking Capacity(6 weeks)
- Change in Balance(6 weeks)
- Change in Freezing of Gait (FOG)(6 weeks)
- Change in Motor Symptoms(6 weeks)
- Change in Caregiver QOL(6 weeks)
- Change in Quality of Life (QOL)(6 weeks)