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Intensive Upper Limb Therapy for Stroke (SUPER Trial)

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

Summary

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

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.
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.
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.

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.
Select...
I have been diagnosed with advanced dementia.
Select...
I have had an arm injury that affects my ability to move it or causes significant pain.
Select...
I was significantly independent before my stroke.

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
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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
Change in functional gross and fine motor coordination as assessed by the Action Research Arm Test (ARAT)
Secondary outcome measures
Change in anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)
Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)
Change in degree of disability as assessed by the Modified Rankin Scale (mRS)
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment
2013
Completed Phase 2
~10240

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
934 Previous Clinical Trials
333,799 Total Patients Enrolled
45 Trials studying Stroke
9,528 Patients Enrolled for Stroke
Sean SavitzPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

intenSive UpPer Extremity Recovery Program Clinical Trial Eligibility Overview. Trial Name: NCT05689502 — N/A
Stroke Research Study Groups: Treatment
Stroke Clinical Trial 2023: intenSive UpPer Extremity Recovery Program Highlights & Side Effects. Trial Name: NCT05689502 — N/A
intenSive UpPer Extremity Recovery Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05689502 — N/A
~4 spots leftby Sep 2025
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