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Exoskeleton for Parkinson's Disease

N/A

Waitlist Available

Led By Mark S Baron, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Modified H&Y stage II-V

Be older than 18 years old

Must not have

Neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination

Severe CHF, COPD, or those requiring nasal canula O2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate post-training

Awards & highlights

No Placebo-Only Group

Summary

This trial will research if a lightweight exoskeleton device can help people with Parkinson's Disease improve their balance, walking, quality of life, and independence.

Who is the study for?

This trial is for people with Parkinson's Disease confirmed by a specialist, who can walk at least 20 minutes with an exoskeleton during screening. They should be between stages II-V of the disease and not have severe cognitive issues or other health problems like heart failure or osteoporosis. Participants must be between 5'1" and 6'3" tall, weigh less than 250 pounds, and not have any lower limb amputations.

What is being tested?

The study tests if a portable leg-strapped exoskeleton can help improve walking and reduce falls in Parkinson's patients. Participants will use this device under supervision twice weekly for six weeks while their mobility and quality of life are monitored.

What are the potential side effects?

While specific side effects aren't listed, potential risks may include discomfort from wearing the device, skin irritation where it attaches to the body, muscle strain from new walking patterns, or fatigue due to increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's disease is at a moderate to advanced stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have conditions affecting my movement not related to Parkinson's disease.

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I have severe heart failure, severe lung problems, or need oxygen through a nose tube.

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I have a feeding tube or a port for feeding.

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I have had part of my leg amputated.

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I can't walk for 20 minutes using an exoskeleton during the first test.

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I can't pass the muscle test for walking with the Keeogo device.

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I have had a heart device implanted or heart surgery.

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I feel dizzy or faint when I stand up and move.

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I am shorter than 5'1" or taller than 6'3".

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My body weight is over 250 pounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through last training visit (weeks 1-6, 12 sessions) and 6- and 12-wks post-training

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through last training visit (weeks 1-6, 12 sessions) and 6- and 12-wks post-training

This trial's timeline: 3 weeks for screening, Varies for treatment, and through last training visit (weeks 1-6, 12 sessions) and 6- and 12-wks post-training for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Attrition (Tolerability) Change

Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Change

+2 more

Secondary study objectives

Berg Balance Scale (Suitability as a Future Secondary Efficacy Measure)

Motion Detector Sensors (Suitability as a Future Secondary Efficacy Measure)

Motor examination (Part III) of the modified Unified Parkinson's Disease Rating Scale (Suitability as a Future Secondary Efficacy Measure)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Feasibility and SafetyExperimental Treatment1 Intervention

This is a feasibility study to assess the safety and potential utility of a lightweight ground exoskeleton (Keeogo, B-Temia, Inc.) to enhance mobility in people with Parkinson's disease (PD).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exoskeleton

2018

N/A

~70

0 / 11Eligibility criteria met