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

Not Applicable

Terminated

• Conditions: Parkinson Disease
• Interventions: Device: Robotic-assist gait training device

• Registration Number: NCT04587193
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-14
• Primary Completion: 2022-12-22
• Study Completion: 2023-01-02
• Results First Submitted: 2023-11-17
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Results First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD participants	Robotic-assist gait training device	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).

Primary Outcome Measures

Name	Time	Method
Safety of the Portable Exoskeleton	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 Outcome Measures

Name	Time	Method
Change in Balance	6 weeks	The Berg Balance Scale (BBS) assesses balance via asking the participant to perform 14 functional activities. Each functional activity is rated on a 5 point scale from 0 (unable) to 4 (able safety or with minimal aid). The score on each functional activity is then added to get an overall score from 0 to 56. Scores range from 0 to 56 with higher scores indicating better balance.
Change in Walking Capacity	6 weeks	Walking capacity will be assessed using the 6-Minute Walking Test (6MWT) that assesses distance (in feet) 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. The change in walking capacity from baseline to the week 5 treatment.
Change in Freezing of Gait (FOG)	6 weeks	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).
Change in Motor Symptoms	6 weeks	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 (best score) to 56 (worst score) with higher scores indicating more symptoms.
Change in Caregiver QOL	6 weeks	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. Each item is scored from 0 to 4. Total scores are then added. Total scores range from 0 (no problem at all) to 116 (worst level of problem).
Change in Quality of Life (QOL)	6 weeks	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). All items are then added to get a total score. Total scores can range from 0 to 156. The lower the total score, the better quality of life.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States