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N/A N=361 Randomized Single-blind Treatment

Arm Rehabilitation Study After Stroke

Stroke · Brain Infarction · Brain Ischemia · Cerebral Infarction · Cerebrovascular Disorders

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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