Clinical trial NCT00871715: Arm Rehabilitation Study After Stroke
Official title: Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Brain Infarction
Brain Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Keywords: stroke
hemiparesis
physical therapy
occupational therapy
neurorehabilitation
patient focused
motor learning
motor control
skill acquisition
skill training
motor recovery
task oriented training
task specific training
arm function
hand function
upper extremity
arm therapy
physical rehabilitation
arm rehabilitation
motor function
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-03-30
Enrollment: 361
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Of the 700,000 individuals who experience a new or recurrent stroke each year, a majority have considerable residual disability. Sixty-five percent (65%) of patients at 6 months are unable to incorporate the paretic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reduced quality of life after stroke. The extent of disability has been underplayed by the use of the Barthel Index that captures only basic activities of daily living such as self-care and does not extend to activities and participation at higher levels of functioning that are most affected by a residual upper extremity disability. The past decade has witnessed an explosion of different therapy interventions designed to capitalize on the brain's inherent capability to rewire and learn well into old age and more importantly for rehabilitation, after injury. The most effective arm-focused interventions with the strongest evidence and potentially the most immediate and cost-effective appeal for the current health-care environment share a common emphasis on focused task-specific training applied with an intensity higher than usual care. Therefore, our primary aim is to compare the efficacy of a fully defined, hybrid combination of the most effective interventions (forced-use/constraint-induced therapy and skill-based/impairment-mitigating motor learning training), the Accelerated Skill Acquisition Program (ASAP), to an equivalent dose of usual and customary outpatient therapy.

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.

Primary outcomes:
measure: Wolf Motor Function Test (WMFT) Log-transformed Time
timeFrame: Baseline to 1 year post-randomization
measure: Wolf Motor Function Test Time
timeFrame: Baseline to 1 year post-randomization
measure: Stroke Impact Scale (SIS) Hand Function Subscale Score.
timeFrame: Baseline to 1 year post-randomization
measure: 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)
timeFrame: Baseline to 1 year post-randomization
Secondary outcomes:
measure: Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)
timeFrame: Baseline to 1 year post-randomization
measure: Stroke Impact Scale (SIS) Mobility Subscale Score.
timeFrame: Baseline to 1 year post-randomization
measure: Stroke Impact Scale (SIS) ADL/IADL Subscale Score.
timeFrame: Baseline to 1 year post-randomization
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: Baseline to 1 year post-randomization
measure: Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box
timeFrame: Baseline to 1 year post-randomization
measure: Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength
timeFrame: Baseline to 1 year post-randomization
measure: Arm Muscle Torque Test - Elbow Extensors
timeFrame: Baseline to 1 year post-randomization
measure: Arm Muscle Torque Test - Elbow Flexors
timeFrame: Baseline to 1 year post-randomization
measure: Arm Muscle Torque Test - Shoulder Extensors
timeFrame: Baseline to 1 year post-randomization
measure: Arm Muscle Torque Test - Shoulder Flexors
timeFrame: Baseline to 1 year post-randomization
measure: Arm Muscle Torque Test - Wrist Extensors
timeFrame: Baseline to 1 year post-randomization
measure: Arm Muscle Torque Test - Wrist Flexors
timeFrame: Baseline to 1 year post-randomization
measure: As-Tex Sensory Index
timeFrame: Baseline to 1 year post-randomization
measure: Upper Extremity Fugl Meyer (UEFM), Motor Component
timeFrame: Baseline to 1 year post-randomization
measure: D-KEFS Verbal Fluency Test
timeFrame: Baseline to 1 year post-randomization
measure: Digits Span Backward
timeFrame: Baseline to 1 year post-randomization
measure: Hopkins Verbal Learning Test, Revised (HVLT-R)
timeFrame: Baseline to 1 year post-randomization
measure: Color Trails Making Tests 1 & 2
timeFrame: Baseline to 1 year post-randomization
measure: Short Blessed Memory Test
timeFrame: Baseline to 1 year post-randomization
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline to 1 year post-randomization
measure: Confidence in Arm & Hand Movement (CAHM)
timeFrame: Baseline to 1 year post-randomization
measure: Stroke Impact Scale (SIS) Communication Subscale Score.
timeFrame: Baseline to 1 year post-randomization
measure: Stroke Impact Scale (SIS) Emotion Subscale Score.
timeFrame: Baseline to 1 year post-randomization
measure: Motor Activity Log 28 QOM (MAL-28)
timeFrame: Baseline to 1 year post-randomization
measure: EQ5D
timeFrame: Baseline to 1 year post-randomization
measure: Satisfaction With Life Scale (SWLS)
timeFrame: Baseline to 1 year post-randomization
measure: Single-Item Subjective Quality of Life Measurement (SQOL)
timeFrame: Baseline to 1 year post-randomization
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Baseline to 1 year post-randomization
Other outcomes:
measure: Monthly Telephone Interviews
timeFrame: monthly, beginning 30 days post-randomization
measure: Post-Intervention Interview
timeFrame: 16-20 weeks post-randomization
measure: Exit Interview
timeFrame: Post-intervention to 1 year post-randomization
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Los Angeles
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Huntington Rehabilitation Medicine Associates
state: California
city: Los Angeles
country: United States
facility: Casa Colina Centers for Rehabilitation
state: California
city: Washington
country: United States
facility: National Rehabilitation Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: University of Southern California
name: Carolee J. Winstein, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: MedStar National Rehabilitation Network
name: Alexander Dromerick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Steven Wolf, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Monica A Nelsen, DPT, PT
role: STUDY_DIRECTOR
References:
citation: Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, Blanton S, Scott C, Reiss A, Cen SY, Holley R, Azen SP; ICARE Investigative Team. Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol. BMC Neurol. 2013 Jan 11;13:5. doi: 10.1186/1471-2377-13-5.
citation: Duff SV, He J, Nelsen MA, Lane CJ, Rowe VT, Wolf SL, Dromerick AW, Winstein CJ. Interrater reliability of the Wolf Motor Function Test-Functional Ability Scale: why it matters. Neurorehabil Neural Repair. 2015 Jun;29(5):436-43. doi: 10.1177/1545968314553030. Epub 2014 Oct 16.
citation: Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, Cen SY, Azen SP; Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Investigative Team. Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):571-81. doi: 10.1001/jama.2016.0276.
citation: Martinez C, Bacon H, Rowe V, Russak D, Fitzgerald E, Woodbury M, Wolf SL, Winstein C. A Reaching Performance Scale for 2 Wolf Motor Function Test Items. Arch Phys Med Rehabil. 2020 Nov;101(11):2015-2026. doi: 10.1016/j.apmr.2020.05.003. Epub 2020 May 17.
citation: Lewthwaite R, Winstein CJ, Lane CJ, Blanton S, Wagenheim BR, Nelsen MA, Dromerick AW, Wolf SL. Accelerating Stroke Recovery: Body Structures and Functions, Activities, Participation, and Quality of Life Outcomes From a Large Rehabilitation Trial. Neurorehabil Neural Repair. 2018 Feb;32(2):150-165. doi: 10.1177/1545968318760726.
citation: Rowe VT, Winstein CJ, Wolf SL, Woodbury ML. Functional Test of the Hemiparetic Upper Extremity: A Rasch Analysis With Theoretical Implications. Arch Phys Med Rehabil. 2017 Oct;98(10):1977-1983. doi: 10.1016/j.apmr.2017.03.021. Epub 2017 Apr 21.