intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)

Chronic Stroke Clinical Trial

— SUPER  

Official title:

intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689502
• Other study ID #: HSC-MS-22-0774
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Sean Savitz
• Phone: (713) 500-7083
• Email: Sean.I.Savitz[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: December 31, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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
Primary	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
Primary	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	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	Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary	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.	Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary	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)	Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary	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	Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary	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	Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary	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	Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary	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	Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary	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	Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary	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	Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention