Arm Rehabilitation Study After Stroke

NCT00871715 | Completed Results DMC

• 1 other identifier: U01NS056256
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (4)

• Wolf Motor Function Test (WMFT) Log-transformed Time

  Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity.

  Baseline to 1 year post-randomization

• Wolf Motor Function Test Time

  Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity.

  Baseline to 1 year post-randomization

• Stroke Impact Scale (SIS) Hand Function Subscale Score.

  Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function.

  Baseline to 1 year post-randomization

• 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)

  The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses.

  Baseline to 1 year post-randomization

Secondary Outcomes (28)

• Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)

  Baseline to 1 year post-randomization

• Stroke Impact Scale (SIS) Mobility Subscale Score.

  Baseline to 1 year post-randomization

• Stroke Impact Scale (SIS) ADL/IADL Subscale Score.

  Baseline to 1 year post-randomization

• National Institute of Health Stroke Scale (NIHSS)

  Baseline to 1 year post-randomization

• Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box

  Baseline to 1 year post-randomization

Other Outcomes (3)

• Monthly Telephone Interviews

  monthly, beginning 30 days post-randomization

• Post-Intervention Interview

  16-20 weeks post-randomization

• Exit Interview

  Post-intervention to 1 year post-randomization

Study Arms (3)

ASAP

EXPERIMENTAL

A focused, intense, evidence-based, upper extremity rehabilitation program, administered during the early post-acute outpatient interval. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence.

Behavioral: Accelerated Skill Acquisition Program (ASAP)

DEUCC

ACTIVE COMPARATOR

Dose-equivalent usual and customary arm therapy administered early post-acutely in the outpatient setting. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.

Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC

UCC

OTHER

Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group with treatment dose administered in accordance with usual and customary practices.

Behavioral: Usual and Customary Care - UCC

Interventions

Accelerated Skill Acquisition Program (ASAP) BEHAVIORAL

A 30-hour dose is administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session precedes the first visit.

Also known as: ASAP

ASAP

Dose-Equivalent Usual & Customary Care - DEUCC BEHAVIORAL

Usual and customary arm therapy administered early post-acutely in the outpatient setting, adjusted for dose, but otherwise administered in accordance with usual and customary practices. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.

Also known as: DEUCC

DEUCC

Usual and Customary Care - UCC BEHAVIORAL

Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group and treatment dose will be administered in accordance with usual and customary practices.

Also known as: UCC

UCC

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (8)

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Rancho Los Amigos National Rehabilitation Center

Los Angeles, California, 90242, United States

Location

Long Beach Memorial Medical Center

Los Angeles, California, 90806, United States

Location

Huntington Rehabilitation Medicine Associates

Los Angeles, California, 91105, United States

Location

Casa Colina Centers for Rehabilitation

Los Angeles, California, 91769, United States

Location

National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (6)

• 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.

  PMID: 23311856 BACKGROUND

• 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.

  PMID: 25323459 BACKGROUND

• 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.

  PMID: 26864411 RESULT

• 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.

  PMID: 32433993 DERIVED

• 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.

  PMID: 29554849 DERIVED

• 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.

  PMID: 28434819 DERIVED

Related Links

• ICARE Administrative Headquarters: USC Department of Biokinesiology \& Physical Therapy
• ICARE Clinical Site: Casa Colina Rehabilitation Centers
• ICARE Clinical Center: National Rehabilitation Hospital
• ICARE Clinical Site: Huntington Rehabilitation Medical Associates
• ICARE Clinical Site: Rancho Los Amigos National Rehabilitation Center
• ICARE Clinical Center: Emory University
• ICARE Clinical Site: Long Beach Memorial Medical Center
• ICARE Clinical Site: Cedars Sinai Medical Center

MeSH Terms

Conditions

Stroke; Brain Infarction; Brain Ischemia; Cerebral Infarction; Cerebrovascular Disorders; Paresis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Carolee Winstein, Principal Investigator
• Organization: University of Southern California

winstein@usc.edu

3234422903

Study Officials

• Carolee J. Winstein, PhD, PT

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Alexander Dromerick, MD

  MedStar National Rehabilitation Network

  PRINCIPAL INVESTIGATOR

• Steven Wolf, PhD, PT

  Emory University

  PRINCIPAL INVESTIGATOR

• Monica A Nelsen, DPT, PT

  University of Southern California

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 9, 2019
• Results First Posted: April 27, 2016

Record last verified: 2019-06

Locations

US (8)