Chronic Stroke
Conditions
Keywords
chronic stroke, stroke, arm impairment
Brief summary
The purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients.
Interventions
OTHERStandard Occupational Therapy Arm Exercise Program
Standard exercise program will be provided addressing shoulder, elbow, forearm, wrist, and hand with expectation that participant will complete 3 times a week. Exercise program will be updated at assessment timepoints as needed with change in arm function.
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 1 month post stroke * Score of at least 2-/5 on Manual Muscle Test for wrist flexors or extensors, indicating adequate movement to complete robotic device use * Able to follow written instructions
Exclusion criteria
* Prior arm injury impacting available passive or active range of motion or significant arm pain with movement * Underlying brain pathologies such as metastatic or primary brain malignancies, comorbid multiple sclerosis, etc. * Prior significant drug or alcohol abuse * Diagnosed with dementia * Pre-stroke baseline modified Rankin Scale (mRS) \>3 * History of seizure/epilepsy * History of clinically significant ischemic or hemorrhagic stroke prior to index stroke resulting in prior arm injury or weakness. * Pregnancy * Contraindication to MRI or Transcranial Magnetic Stimulation (TMS). * Medical instability assessed by the treating stroke physician to participate to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment | Baseline, month 4, month 8, month 12, month 16, month 20, month 24 | This is a 33 item assessment and each is scored from 0 \[unable to perform as instructed\] - 2 \[faultless performance\] with a maximum score of 66. A higher number indicates better arm function. |
Secondary
| Measure | Time frame |
|---|---|
| Change in integrity of corticospinal tract fibers as assessed by MRI with Diffusion Tensor Imaging (DTI). | Baseline, month 24 |
| Change in motor evoked potential as assessed by Transcranial Magnetic Stimulation | Baseline, month 4, month 8, month 12, month 16, month 20, month 24 |
Countries
United States
Outcome results
None listed