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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05689502
Other study ID # HSC-MS-22-0774
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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