N/A
N=361
Arm Rehabilitation Study After Stroke
Stroke · Brain Infarction · Brain Ischemia · Cerebral Infarction · Cerebrovascular Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00871715 ↗Enrolled (actual)
361
Serious AEs
9.6%
Results posted
Apr 2016
Primary outcome: Primary: Wolf Motor Function Test (WMFT) Log-transformed Time — -0.8; -0.9; -0.8 log(seconds)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Accelerated Skill Acquisition Program (ASAP) (Behavioral); Dose-Equivalent Usual & Customary Care - DEUCC (Behavioral); Usual and Customary Care - UCC (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wolf Motor Function Test (WMFT) Log-transformed Time |
-0.8; -0.9; -0.8 | — |
| PRIMARY Wolf Motor Function Test Time |
-8.1; -8.7; -7.5 | — |
| PRIMARY Stroke Impact Scale (SIS) Hand Function Subscale Score. |
37.6; 35.7; 37.1 | — |
| PRIMARY Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) |
72.7; 72.1; 68.7 | — |
| SECONDARY Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) |
— | — |
| SECONDARY Stroke Impact Scale (SIS) Mobility Subscale Score. |
11.22; 12.08; 14.91 | — |
| SECONDARY Stroke Impact Scale (SIS) ADL/IADL Subscale Score. |
22.69; 21.53; 23.22 | — |
| SECONDARY National Institute of Health Stroke Scale (NIHSS) |
-1.67; -1.61; -1.76 | — |
| SECONDARY Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box |
— | — |
| SECONDARY Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength |
— | — |
| SECONDARY Arm Muscle Torque Test - Elbow Extensors |
20.0; 15.73; 14.58 | — |
| SECONDARY Arm Muscle Torque Test - Elbow Flexors |
30.41; 20.78; 24.21 | — |
| SECONDARY Arm Muscle Torque Test - Shoulder Extensors |
25.61; 20.76; 18.64 | — |
| SECONDARY Arm Muscle Torque Test - Shoulder Flexors |
21.41; 24.4; 19.74 | — |
| SECONDARY Arm Muscle Torque Test - Wrist Extensors |
15.19; 18.07; 18.12 | — |
| SECONDARY Arm Muscle Torque Test - Wrist Flexors |
16.24; 10.71; 8.96 | — |
| SECONDARY As-Tex Sensory Index |
— | — |
| SECONDARY Upper Extremity Fugl Meyer (UEFM), Motor Component |
— | — |
| SECONDARY D-KEFS Verbal Fluency Test |
— | — |
| SECONDARY Digits Span Backward |
— | — |
| SECONDARY Hopkins Verbal Learning Test, Revised (HVLT-R) |
— | — |
| SECONDARY Color Trails Making Tests 1 & 2 |
— | — |
| SECONDARY Short Blessed Memory Test |
— | — |
| SECONDARY Patient Health Questionnaire 9 (PHQ-9) |
— | — |
| SECONDARY Confidence in Arm & Hand Movement (CAHM) |
— | — |
| SECONDARY Stroke Impact Scale (SIS) Communication Subscale Score. |
6.23; 2.97; 3.11 | — |
| SECONDARY Stroke Impact Scale (SIS) Emotion Subscale Score. |
3.49; 3.63; 3.36 | — |
| SECONDARY Motor Activity Log 28 QOM (MAL-28) |
— | — |
| SECONDARY EQ5D |
— | — |
| SECONDARY Satisfaction With Life Scale (SWLS) |
— | — |
| SECONDARY Single-Item Subjective Quality of Life Measurement (SQOL) |
— | — |
| SECONDARY Reintegration to Normal Living Index (RNLI) |
— | — |
Summary
This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage & content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.
Eligibility Criteria
INCLUSION
Ischemic or hemorrhagic stroke.
Hemiparesis in an upper extremity.
Age 21+.
Able to communicate in English (or Spanish,Rancho Los Amigos site only).
Willing to attend outpatient therapy & f/u evaluations for 1 yr.
Some active finger extension.
EXCLUSION
Traumatic or non-vascular brain injury, subarachnoid hemorrhage, AV malformation.
History of psychiatric illness requiring hospitalization within past 24 mos.
Active drug treatment for dementia.
Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS).
History of head trauma requiring >48 hours of hospitalization within past 12 mos.
Amputation of all fingers or thumb of hemiparetic (weak) arm.
Treated with Botox in affected arm within last 3 months.
Data sourced from ClinicalTrials.gov (NCT00871715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.