Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05689502

intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Chronic Stroke

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment

Device

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: SUPER

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.