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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Robotic-assist gait training device


Participation Criteria
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Eligibility Criteria
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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 1) Unwilling to complete questionnaire

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD participants<br>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). | Device: Robotic-assist gait training device<br>* PD participants will walk while wearing a robotic-assist gait training device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the portable exoskeleton | Number of prevented or near falls requiring physical assistance by the investigative training team experienced by the participant during throughout the training. | At the end of treatment (5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking capacity | Walking capacity will be assessed using the 6-Minute Walking Test (6MWT) that assesses distance walked to determine aerobic capacity and endurance. Participants will be asked to walk as far as possible in 6 minutes and the total distance will be recorded. | Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) | 
| Change in freezing of gait (FOG) | FOG will be assessed using the 6MWT. FOG will be assess using 2 gait related questions on the Unified Parkinson's Disease Rating Scale (UPDRS). Scores are summed and range from 0 (normal) to 4 (very poor). | Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) | 
| Change in balance | The Berg Balance Scale (BBS) assesses balance via asking the participant to perform 14 functional activities. Ability to perform the functions is rated on a 5 point scale from 0 (unable) to 4 (able safety or with minimal aid). Scores range from 0 to 56 with higher scores indicating better balance. | Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) | 
| Change in motor symptoms | The Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part IIIMDS-UPDRS, part III will be used to assess motor symptoms and fluctuations of Parkinson Disease (PD) This outcome measure will be used to report a change in PD motor symptoms from baseline. Scores range from 0 to 56 with higher scores indicating more symptoms. | Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) | 
| Change in quality of life (QOL) | Parkinson's Disease Questionnaire (PDQ39) is a 39 item self-report questionnaire assessing how often patients experience difficulties across the 8 quality of life dimensions of functioning and well-being. Items are scored from 0 (never) to 4 (always) and can be summed in the PDQ39 Summary Index with lower scores indicating better QOL. | Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) | 
| Change in Caregiver QOL | Participant's caregivers QOL will be assessed using the Parkinson's Disease Carer Questionnaire (PD-Carer), a 29 item measure of health related quality of life for use with carers of people with Parkinson's disease. Scores range from 0 (no problem at all) to 100 (worst level of problem). | Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, Balance, Freezing