Back to resultsintenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER) (SUPER)
Primary Purpose
Chronic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stroke focused on measuring Rehabilitation, Arm recovery, High intensity therapy, Occupational therapy, Physical therapy
Eligibility Criteria
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.
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Change in integrity of the contralateral corticospinal tract fibers as assessed by the MRI with Diffusion Tensor Imaging (DTI) evaluation
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
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
Secondary Outcome Measures
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
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.
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)
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
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
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
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
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
Full Information
NCT ID
NCT05689502
First Posted
January 9, 2023
Last Updated
March 29, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05689502
Brief Title
intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)
Acronym
SUPER
Official Title
intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
Rehabilitation, Arm recovery, High intensity therapy, Occupational therapy, Physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Treatment
Intervention Description
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 Outcome Measure Information:
Title
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
Title
Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
Description
This is a 66 item questionnaire and each is scored from 0(cannot perform)-2(performs fully) a higher score indicating better outcome
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Title
Change in functional gross and fine motor coordination as assessed by the Action Research Arm Test (ARAT)
Description
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
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary Outcome Measure Information:
Title
Change in degree of disability as assessed by the Modified Rankin Scale (mRS)
Description
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
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Title
Change in performance in activities of daily living as assessed by the Barthel Index (BI)
Description
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.
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Title
Change in fatigue as assessed by the Neurological Fatigue Index (NFI)
Description
This is a 12 item questionnaire and each is scored on a 4 point Likert scale from 0(strongly disagree) to 3(strongly agree)
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Title
Change in anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)
Description
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
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Title
Change in depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
Description
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
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Title
Change in functional ability of the hemiplegic arm and hand to perform meaningful tasks as assessed by the Chedoke Arm and Hand Inventory (CAHAI)
Description
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
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Title
Change in difficulty to care for the affected arm as assessed by the Arm Activity Measure A
Description
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
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Title
Change in difficulty in completing functional tasks with the affected arm as assessed by the Arm Activity Measure B
Description
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
Time Frame
Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Savitz
Phone
(713) 500-7083
Email
Sean.I.Savitz@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Stevens, OTR
Phone
713-500-7914
Email
emily.a.stevens@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Savitz
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Savitz, MD
Phone
713-500-7083
Email
Sean.I.Savitz@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Emily Stevens, OTR
Phone
713-500-7914
Email
emily.a.stevens@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)
We'll reach out to this number within 24 hrs