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Powered Orthotic Exoskeleton

Powered Orthotic Exoskeleton for Stroke (POETS Trial)

N/A
Waitlist Available
Led By Ann M Spungen, EdD
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
Able to walk between 0.15-0.75m/s
Hemiplegia or hemiparesis due to stroke (>6 months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline after completing 36 training sessions (approximately 3 months time)
Awards & highlights

POETS Trial Summary

This trial is testing a new battery-powered device, called the Keeogo, which is worn around the legs and helps with knee movement, sitting, and standing. The device is easy to use and could help improve the ability to walk, muscle mass and strength, and quality of life.

Who is the study for?
This trial is for adults aged 18-89 who have had a stroke at least 6 months ago, resulting in difficulty walking due to leg weakness or stiffness. Participants should be able to walk slowly but want to improve their mobility and commit to the study requirements. They must weigh under 250lbs and not have severe spasticity, certain range of motion limitations, or conditions that would make using the exoskeleton unsafe.Check my eligibility
What is being tested?
The Keeogo powered orthotic exoskeleton is being tested for its ability to assist with knee movement during walking, sitting down, and standing up in individuals affected by stroke. The device aims to improve walking ability, muscle strength, general health, motivation for increased activity levels and access previously inaccessible places.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include discomfort from wearing the device, skin irritation where it contacts the body or strain from unfamiliar movements. Any unexpected reactions will be monitored throughout the trial.

POETS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk at a slow to moderate pace.
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I have weakness or paralysis on one side of my body due to a stroke that occurred over 6 months ago.
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I have had partial or full paralysis on one side of my body due to a stroke that occurred over 6 months ago.
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I am willing and able to follow the study's requirements and communicate my needs.
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I have difficulty moving or walking because of stiffness and limited movement in my knee.
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I am between 18 and 89 years old.
Select...
I am between 18 and 89 years old.
Select...
I have difficulty moving or walking because of stiffness and limited movement in my knee.

POETS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline after completing 36 training sessions (approximately 3 months time)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline after completing 36 training sessions (approximately 3 months time) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Five Times Sit to Stand Test (5xSTS)
Secondary outcome measures
Ratio of stance time of each limb during ambulation
energy expenditure

POETS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Powered Orthotic Exoskeleton Training GroupExperimental Treatment2 Interventions
Participant in 36 session ambulation training using a powered orthotic exoskeleton.
Group II: Control GroupActive Control1 Intervention
Participant in 36 session ambulation training without using a powered orthotic exoskeleton.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Keeogo
2017
N/A
~20

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,576 Total Patients Enrolled
82 Trials studying Stroke
6,599 Patients Enrolled for Stroke
Ann M Spungen, EdDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
6 Previous Clinical Trials
857 Total Patients Enrolled

Frequently Asked Questions

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

Is this clinical trial open to participants younger than 45 years old?

"This medical trial has specified that all participants must be aged between 18 and 89. For those too young and too old, there are 37 trials designed for minors and 1007 studies available to patients above the age of 65."

Answered by AI

Are there any vacancies currently available for participants in this clinical research program?

"Affirmative, the clinicaltrials.gov data affirms that this experiment is presently enrolling patients. It was initially posted on November 2nd 2020 and has been updated most recently on June 3rd 2022. 24 volunteers are required to be recruited from one specific medical site."

Answered by AI

Am I able to partake in this clinical trial given my particular circumstances?

"This clinical trial seeks 24 individuals aged 18 to 89 years old who have had a stroke. To qualify, candidates must demonstrate hemiplegia or hemiparesis due to stroke (>6 months), self-reported mobility issues and reduced range of motion in the affected knee, weigh below 250lbs, desire an increase in daily activity levels, be able and willing to comply with instructions given by study staff and communicate basic needs. Both males and females are welcome to apply."

Answered by AI

What is the current enrollment of participants in this research project?

"Affirmative. As evidenced on clinicaltrials.gov, this medical experiment is presently recruiting participants. It was first listed in November 2020 and has been amended most recently June 2022; the research requires 24 individuals to join at a single site."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
James J. Peters VA Medical Center, Bronx, NY
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. James J. Peters VA Medical Center, Bronx, NY: < 24 hours
Average response time
  • < 1 Day
~1 spots leftby Jun 2024