Stroke-induced he,Iparesis in the Arm Clinical Trial
Official title:
Mental Practice in Chronic Stroke-Induced Hemiparesis
This study will examine whether mentally rehearsing moving one's affected arm after stroke will improve the quality and amount of affected arm movement. The study will enroll 100 people who have experienced a stroke > 1 year ago, and who still have difficulty moving their affected wrists and hands. Eligible subjects also cannot have any implanted devices or metal above the waist. Each patient will receive 10 weeks of therapy targeting their affected arms. Half of the subjects will also be administered mental rehearsal of the exercises that they are physically performing, while the other half will be administered stroke information and information on additional exercises that they can perform targeting their affected arms. Tests of arm movement and use will be given before and after intervention, as well as 3 months after intervention, to measure response to these interventions. We will also administer brain scans before and after intervention. We hypothesize that people receiving the mantal and physical rehearsal will show larger arm movement and use changes.
| Status | Active, not recruiting |
| Enrollment | 100 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 75 Years |
| Eligibility |
Inclusion Criteria:(1) Minimum motor criteria: able to at least actively flex the affected
wrist a minimum of 10 degrees and actively flex the MP joints of the thumb, and at least 2
additional MP joints in two additional fingers at least 10 degrees. These movements must
be repeated at least 3 times in one minute. Additionally, subjects in this study will have
to exhibit the aforementioned active range of motion and a FM score of 28 to be eligible
for study inclusion. (2) stroke experienced > 1 year prior to study enrollment; (3) a
score > 25 on the Folstein Mini Mental Status Examination (MMSE), (4) age > 21 < 75; (5)
have experienced one stroke; (6) discharged from all forms of physical rehabilitation. Exclusion Criteria:(1) < 21 years old; (2) excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale; (3) excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of > 2 on the Modified Ashworth Spasticity Scale;92 (4) currently participating in any experimental rehabilitation or drug studies; (5) mirror movements (i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand); (6) contraindication to a MRI procedure (i.e., metal implants, claustrophobia) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Cincinnati/Drake Center | Cincinnati | Ohio |
| United States | MetroHeealth/Cleveland Clinic | Cleveland | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Action Research Arm test | Twice before intervention phase; once directly after intervention phase; once 3 months after intervention phase | No |