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Intensive Upper Limb Therapy for Stroke (SUPER Trial)

Houston, TX

N/A

Recruiting

Led By Sean Savitz

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

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

Must have

Able to tolerate 6 hours of therapy a day

Single qualifying stroke event as confirmed by CT or MRI

Must not have

History of clinically significant ischemic or hemorrhagic stroke resulting in prior arm weakness in the same territory as the index stroke

Diagnosed with advanced dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial explores the effects of intensive, high-quality upper limb therapy to improve motor skills, function, and quality of life.

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Who is the study for?

The SUPER trial is for individuals who had a stroke at least 6 months ago, can follow instructions, and handle 6 hours of daily therapy. They should have moderate arm impairment (Fugl-Meyer score of 20-45) confirmed by imaging tests. People with prior significant arm injuries, severe pre-stroke disability, other strokes causing similar symptoms, medical instability, substance abuse issues or advanced dementia cannot participate.Check my eligibility

What is being tested?

This study tests an intensive upper extremity therapy program designed to improve the function and quality of life in chronic stroke survivors. It focuses on high-quality treatment that's both high-dose and high-intensity to see if it's feasible and effective.See study design

What are the potential side effects?

Since this trial involves physical therapy rather than medication, side effects may include muscle soreness or fatigue due to the intensity of the exercises. However, specific side effects will depend on individual tolerance to the therapy regimen.

Eligibility Criteria

Inclusion Criteria

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

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I can handle 6 hours of therapy daily.

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I had a stroke confirmed by a scan.

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Exclusion Criteria

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

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I have had a stroke before that caused weakness in my arm.

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I have been diagnosed with advanced dementia.

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I have had an arm injury that affects my ability to move it or causes significant pain.

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I was significantly independent before my stroke.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention for reporting.