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

Virginia Commonwealth University (VCU)

Status: Terminated

Conditions: Parkinson Disease

Treatments: Device: Robotic-assist gait training device

Study type: Interventional

Funder types: Other

Identifiers

NCT04587193

HM20020066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 21 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

PD participants

Experimental group

Description:

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).

Treatment:

Device: Robotic-assist gait training device