intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)

NCT05689502 | Active Not Recruiting FDA Device

• 1 other identifier: HSC-MS-22-0774
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Stroke

Keywords

Rehabilitation; Arm recovery; High intensity therapy; Occupational therapy; Physical therapy

Outcome Measures

Primary Outcomes (3)

• Change in integrity of the contralateral corticospinal tract fibers as assessed by the MRI with Diffusion Tensor Imaging (DTI) evaluation

  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

  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)

  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 Outcomes (9)

• Change in degree of disability as assessed by the Modified Rankin Scale (mRS)

  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)

  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)

  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)

  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)

  Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention

Other Outcomes (2)

• Number of participants that had a positive perception of the intervention as indicated by the semi structured interview

  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

  Once between 6 week and 6 month assessments.

Study Arms (1)

Treatment

EXPERIMENTAL

Device: Treatment

Interventions

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Sean Savitz

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 19, 2023
• Study Start: March 20, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)