Chronic StrokeSUPERNCT05689502
intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)
A study testing Treatment in people with Chronic Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
- Being tested
- Treatment
- Keywords
- Rehabilitation, Arm recovery, High intensity therapy, Occupational therapy, Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in integrity of the contralateral corticospinal tract fibers as assessed by the MRI with Diffusion Tensor Imaging (DTI) evaluation
Measured: 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
Measured: 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
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
This is a 12 item questionnaire and each is scored on a 4 point Likert scale from 0(strongly disagree) to 3(strongly agree)
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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
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
Measured: 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
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
Measured: 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)
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome
Measured: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start20 Mar 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Savitz, The University of Texas Health Science Center, Houston
- Investigators
- Sean Savitz, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689502
- Sponsor's protocol ID
- HSC-MS-22-0774
- Acronym
- SUPER
- Status last verified
- Dec 2025
- First submitted
- 9 Jan 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)
- ClinicalTrials.gov ID
- NCT05689502
- Acronym / sponsor ID
- SUPER / HSC-MS-22-0774
- Conditions
- Chronic Stroke
- Keywords
- Rehabilitation, Arm recovery, High intensity therapy, Occupational therapy, Physical therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentSubjects 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. | Device | Treatment |
Primary outcome
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
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
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
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Savitz principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Chronic Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.