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Exoskeleton for Parkinson's Disease

Q: Which population is most likely to benefit from participation in this trial?

<p>Participants that have been diagnosed with <a href="https://www.withpower.com/clinical-trials/parkinson">Parkinson</a>'s and are between 18-90 years of age may be eligible to join this clinical trial. Approximately 30 participants must be recruited for the study to proceed.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate post-training

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,573 Total Patients Enrolled

Mark S Baron, MDPrincipal InvestigatorHunter Holmes McGuire VA Medical Center, Richmond, VA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which population is most likely to benefit from participation in this trial?

"Participants that have been diagnosed with Parkinson's and are between 18-90 years of age may be eligible to join this clinical trial. Approximately 30 participants must be recruited for the study to proceed."

Answered by AI

Are elderly individuals being admitted for participation in this investigation?

"This trial is open to patients aged between 18 and 90. Separately, there are 24 trials for those under the age of majority and 536 for individuals over 65 years old."

Answered by AI

Is this experiment actively seeking participants?

"Per the data on clinicaltrials.gov, this medical research effort is not currently enrolling patients; the trial was first launched October 1st 2023 and its most recent update occurred September 5th 2023. However, there are presently over 500 other studies that require participants."

Answered by AI

What objectives are researchers hoping to realize through this experiment?

"The primary objective of this clinical trial, which will take place over a 6-week period with 12 sessions in total, is to measure the tolerability and attrition rate. As secondary objectives, Berg Balance Scale (BBS), motion detector sensors and University of Alabama at Birmingham Study of Aging Life-Space Assessment (UAB LSA) are assessed for suitability as future efficacy measures. Post-training assessments after 6 weeks and 12 weeks will be used to estimate how long effects last."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease

2024. "Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028529.