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Behavioural Intervention

Exoskeleton-Assisted Therapy for Stroke

N/A

Waitlist Available

Led By Brittney C Muir, PhD

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

Have a Fugl-Meyer Upper Extremity score of 29-42 for moderately impaired (aim 1) or 0-28 for severely impaired (aim 1 and 2)

Suffered a stroke within the past 1-6 months (aim 1) or 1 week (aim 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

Study Summary

This trial looks at how robot-assisted therapy can improve stroke survivor recovery by facilitating repetitive task training. It has the potential to give Veterans increased quality of life.

Who is the study for?

This trial is for stroke survivors over 18 who fit within the Harmony exoskeleton's size limits. Participants should have moderate to severe upper limb impairment, as measured by a specific score, and must have had their stroke recently (1 week to 6 months prior). Those with unstable health conditions, severe joint pain in the limbs, cognitive or language barriers, multiple strokes, seizures or significant communication issues cannot join.Check my eligibility

What is being tested?

The study is testing two new control systems for an arm therapy exoskeleton called Harmony. These systems are designed to help patients perform repetitive tasks correctly during rehabilitation after a stroke. The goal is to see if these controllers can improve daily living activities and quality of life for Veterans.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from wearing the exoskeleton, fatigue from repetitive movements, and possible frustration or psychological effects due to challenges in performing tasks.

Eligibility Criteria

Inclusion Criteria

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

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My arm and hand movement is moderately to severely limited.

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I had a stroke between 1 week and 6 months ago.

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I am over 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from Baseline Action Research Arm Test (ARAT) at 3 weeks

Change from Baseline Fugl-Meyer Upper Extremity (FM-UE) at 3 weeks

Trial Design

2Treatment groups

Experimental Treatment

Group I: early testingExperimental Treatment1 Intervention

up to 5 participants testing the SA controller in one visit

Group II: SA controllerExperimental Treatment2 Interventions

Synergy assistance controller

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,596 Total Patients Enrolled

83 Trials studying Stroke

6,711 Patients Enrolled for Stroke

Brittney C Muir, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

SA controller (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05962697 — N/A

Stroke Research Study Groups: early testing, SA controller

Stroke Clinical Trial 2023: SA controller Highlights & Side Effects. Trial Name: NCT05962697 — N/A

SA controller (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05962697 — N/A

Frequently Asked Questions

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

Is this experiment open to new participants?

"Information found on clinicaltrials.gov reveals that recruitment for this particular trial is not presently underway. It was initially published April 1st 2024 and last updated July 18th 2023, but there are still 1103 other ongoing studies actively recruiting eligible candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Upper Extremity Exoskeleton to Target Unwanted Joint Synergies During Repetitive Training in Stroke Survivors

2024. "An Upper Extremity Exoskeleton to Target Unwanted Joint Synergies During Repetitive Training in Stroke Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05962697.