intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER) (SUPER)

December 2, 2025 updated by: Sean Savitz, The University of Texas Health Science Center, Houston
The purpose of this study is to Investigate the feasibility of a high-quality, high-dose, high-intensity upper extremity therapy program and to assess the treatment effects of a high-quality, high-dose, high-intensity upper extremity therapy program on functional outcomes, motor impairment, and quality of life

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Single qualifying stroke event as confirmed by CT or MRI
  • At least 6 months post stroke
  • Fugl-Meyer upper extremity (UE) score of 20-45
  • Able to follow written instructions
  • Able to tolerate 6 hours of therapy a day

Exclusion Criteria:

  • Prior arm injury impacting available passive or active range of motion or significant arm pain with movement
  • Active drug or alcohol abuse
  • Diagnosed with advanced dementia
  • Pre-stroke baseline mRS>3
  • History of clinically significant ischemic or hemorrhagic stroke resulting in prior arm weakness in the same territory as the index stroke
  • Medical instability assessed by the treating stroke physician to participate to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Device: Treatment
Subjects will participate in 6 hours of therapy a day, 5 days a week, for 3 consecutive weeks. These sessions will include 2 hours of occupational therapy, 2 hours of physical therapy, and 2 hours of guided individual work. Some of these sessions will be in a group setting. The therapy sessions will be individualized to the subject's personal goals and will focus on improving the function of the arm most affected by the stroke. Sessions may include electrical stimulation of the muscles, if it is determined to be safe. At the end of each week, the therapists will recommend exercises for the subjects to continue to work on at home on the weekend.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in integrity of the contralateral corticospinal tract fibers as assessed by the MRI with Diffusion Tensor Imaging (DTI) evaluation
Time Frame: Baseline(1 week prior to intervention),within 1 week after intervention
Baseline(1 week prior to intervention),within 1 week after intervention
Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This is a 66 item questionnaire and each is scored from 0(cannot perform)-2(performs fully) a higher score indicating better outcome
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Change in functional gross and fine motor coordination as assessed by the Action Research Arm Test (ARAT)
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention

This test has 4 subscales and each measures grasp, grip, pinch and gross movement.

The Grasp subscale has 6 questions and is scored from 0-18, higher score indicating better outcome The Grip subscale has 4 items and is scored from 0-12, higher score indicating better outcome The Pinch subscale has 6 items and is scored from 0-18, higher score indicating better outcome The Gross movement subscale has 3 items and is scored from 0-9, higher score indicating better outcome
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in degree of disability as assessed by the Modified Rankin Scale (mRS)
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
mRS is a 6 point disability scale with possible scores from 0(no disability) to 5(disability requiring constant care) a higher score indicating more disability
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Change in performance in activities of daily living as assessed by the Barthel Index (BI)
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This is a scoring technique that measures performance in ten activities of daily living including feeding, wheelchair to bed transfers, grooming ,chair to toilet transfers, walking, using stairs, dressing, and continence of bowels and bladder. This is a 10 item questionnaire and is scored from 0-100, a higher score indicating higher level of independence.
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Change in fatigue as assessed by the Neurological Fatigue Index (NFI)
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This is a 12 item questionnaire and each is scored on a 4 point Likert scale from 0(strongly disagree) to 3(strongly agree)
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Change in anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This consists of 7 questions and each is scored from 0(not at all) to 3(most of the time) for a maximum score of 21, a higher number indicating more anxiety
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Change in depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This consists of 7 questions and each is scored from 0(not at all) to 3(most of the time) for a maximum score of 21, a higher number indicating more depression
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Change in functional ability of the hemiplegic arm and hand to perform meaningful tasks as assessed by the Chedoke Arm and Hand Inventory (CAHAI)
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This contains 13 tasks and each is scored from 7(complete independence) to 1(total assistance) for a maximum score of 91, a higher number indicating better outcome
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Change in difficulty to care for the affected arm as assessed by the Arm Activity Measure A
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This consists of 8 questions and each is scored from 0(no difficulty) to 4(unable to do activity) for a maximum score of 32 a higher number indicating worse outcome
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Change in difficulty in completing functional tasks with the affected arm as assessed by the Arm Activity Measure B
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This consists of 13 questions and each is scored from 0(no difficulty) to 4(unable to do activity) for a maximum score of 52 a higher number indicating worse outcome
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of participants that had a positive perception of the intervention as indicated by the semi structured interview
Time Frame: Once between 6 week and 6 month assessments.
Once between 6 week and 6 month assessments.
Number of participants that had functional arm improvement after the intervention as indicated by the semi structured interview
Time Frame: Once between 6 week and 6 month assessments.
Once between 6 week and 6 month assessments.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sean Savitz, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-22-0774

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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