Chronic Stroke
Conditions
Keywords
Rehabilitation, Arm recovery, High intensity therapy, Occupational therapy, Physical therapy
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
Interventions
DEVICETreatment
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment | 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) | 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 |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention | 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) | Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention | 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 difficulty to care for the affected arm as assessed by the Arm Activity Measure A | Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention | 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 | Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention | 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 |
| Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA) | Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention | Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome |
| Change in functional ability of the hemiplegic arm and hand to perform meaningful tasks as assessed by the Chedoke Arm and Hand Inventory (CAHAI) | Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention | 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 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 | 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) | Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention | 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. |
Other
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Outcome results
None listed