Arm Rehabilitation Study After Stroke - Full Text View

Sponsor:	University of Southern California
Collaborators:	National Institute of Neurological Disorders and Stroke (NINDS) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	University of Southern California
ClinicalTrials.gov Identifier:	NCT00871715

Purpose

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.

Condition	Intervention	Phase
Stroke Brain Infarction Brain Ischemia Cerebral Infarction Cerebrovascular Disorders	Behavioral: Accelerated Skill Acquisition Program (ASAP) Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC Behavioral: Usual and Customary Care - UCC	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:

Wolf Motor Function Test (WMFT) time measures: determines the time required to perform 15 standardized tasks with each upper extremity. [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Stroke Impact Scale (SIS)- assesses changes in impairments, disabilities and handicaps following a stroke. [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Arm Muscle Torque Test [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Wolf Motor Function Test (WMFT) strength components [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Upper Extremity Fugl Meyer (UEFM), Motor Component [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
As-Tex Sensory Index [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Motor Activity Log 28 QOM (MAL-28) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Satisfaction with Life Scale (SWLS) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Reintegration to Normal Living Index (RNLI) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Single-Item Subjective Quality of Life Measurement (SQOL) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
EQ5D [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Confidence in Arm & Hand Movement (CAHM) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Short Blessed Memory Test [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
D-KEFS Verbal Fluency Test [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Hopkins Verbal Learning Test, Revised (HVLT-R) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Digits Span Backward [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
Color Trails Making Tests 1 & 2 [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	June 2009
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ASAP 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) 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. Other Name: ASAP
Active Comparator: DEUCC 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 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. Other Name: DEUCC
UCC 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 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. Other Name: UCC

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

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION

Ischemic or hemorrhagic stroke.

Hemiparesis in an upper extremity.

Age 21+.

Able to communicate in English.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871715

Contacts

Contact: Monica A Nelsen, DPT, PT	(323) 224-7081	nelsen@usc.edu
Contact: Carolee Winstein, PhD, PT	(323) 442-2903	winstein@usc.edu

Locations

United States, California
University of Southern California	Recruiting
Los Angeles, California, United States, 90033
Contact: Monica A Nelsen, DPT 323-224-7081 nelsen@usc.edu
Contact: Carolee Winstein, PhD 3234422903 winstein@usc.edu
Principal Investigator: Carolee Winstein, PhD, PT
Sub-Investigator: Stanley P. Azen, PhD
Sub-Investigator: Rebecca Lewthwaite, PhD
Sub-Investigator: Monica A. Nelsen, DPT, PT
Sub-Investigator: Christianne J. Lane, PhD
Sub-Investigator: Steven Cen, PhD
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Contact: Michelle Demond 310-423-3148 Michelle.Demond@cshs.org
Contact: Pam Roberts, PhD pamela.roberts@cshs.org
Principal Investigator: Richard V. Riggs, MD
Sub-Investigator: Pamela Roberts, PhD
Sub-Investigator: Arash Asher, MD
Rancho Los Amigos National Rehabilitation Center	Recruiting
Los Angeles (Downey), California, United States, 90242
Contact: Oscar Gallardo, MSPT 562-401-6237 ogallardo@dhs.lacounty.gov
Contact: Babak Bina, M.D. bbina@dhs.lacounty.gov
Principal Investigator: Babak Bina, MD
Sub-Investigator: Oscar Gallardo, MSPT, NCS
Principal Investigator: Burl Wagenheim, PhD
Sub-Investigator: Xiao-Ling Zhang, MD
Long Beach Memorial Medical Center	Recruiting
Los Angeles (Long Beach), California, United States, 90806
Contact: Charro Scott, PT 562-933-0762 cscott@memorialcare.org
Contact: Candice Burtman, MS (562) 933-0762 cburtman@memorialcare.org
Principal Investigator: Richard Adams, MD
Sub-Investigator: Diemha Hoang, MD
Sub-Investigator: Audrey Huang, MD
Sub-Investigator: Charro Scott, PT
Huntington Rehabilitation Medicine Associates	Recruiting
Los Angeles (Pasadena), California, United States, 91105
Contact: Ilin Ohanessians 626-403-1444 ext 104 iohanessians@huntingtonrehab.com
Contact: Cindy Kushi, OTR (626) 403-1444 ckushi@usc.edu
Principal Investigator: Sunil K. Hegde, MD
Casa Colina Centers for Rehabilitation	Recruiting
Los Angeles (Pomona), California, United States, 91769
Contact: Stephanie Kaplan, DPT 909-596-7733 ext 3074 skaplan@casacolina.org
Contact: Cathy Timple, DPT (909) 596-7733 ext 3109 Ctimple@casacolina.org
Principal Investigator: David R Patterson, MD
Sub-Investigator: Stephanie Kaplan, PT, DPT, ATP
United States, District of Columbia
National Rehabilitation Hospital	Recruiting
Washington, District of Columbia, United States, 20010
Contact: Rahsaan Holley, MS, OTR 202-877-1875 Rahsaan.Holley@MedStar.net
Contact: Kate Burdekin Kate.A.Burdekin@MedStar.net
Principal Investigator: Alexander Dromerick, MD
Sub-Investigator: Rahsaan Holley, MS, OTR
United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sarah Blanton, DPT 404-712-2222 sblanto@emory.edu
Contact: Steve Wolf, PhD (404) 712-4801 swolf@emory.edu
Principal Investigator: Steven Wolf, PhD, PT
Sub-Investigator: Sarah Blanton, DPT, NCS
Sub-Investigator: David Burke, MD

Sponsors and Collaborators

University of Southern California

National Institute of Neurological Disorders and Stroke (NINDS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:	Carolee J. Winstein, PhD, PT	University of Southern California
Principal Investigator:	Alexander Dromerick, MD	National Rehabilitation Hospital
Principal Investigator:	Steven Wolf, PhD, PT	Emory University
Study Director:	Monica A Nelsen, DPT, PT	University of Southern California

More Information

Additional Information:

Official web-site of the ICARE Clinical Trial This link exits the ClinicalTrials.gov site

ICARE Administrative Headquarters: USC Department of Biokinesiology & Physical Therapy This link exits the ClinicalTrials.gov site

ICARE Clinical Center: National Rehabilitation Hospital This link exits the ClinicalTrials.gov site

ICARE Clinical Site: Huntington Rehabilitation Medical Associates This link exits the ClinicalTrials.gov site

ICARE Clinical Site: Rancho Los Amigos National Rehabilitation Center This link exits the ClinicalTrials.gov site

ICARE Clinical Center: Emory University This link exits the ClinicalTrials.gov site

ICARE Clinical Site: Long Beach Memorial Medical Center This link exits the ClinicalTrials.gov site

ICARE Clinical Site: Cedars Sinai Medical Center This link exits the ClinicalTrials.gov site

ICARE Data Management & Analysis Center: University of Southern California This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Carolee J. Winstein, PhD, PT, FAPTA (Principal Investigator), University of Southern California
ClinicalTrials.gov Identifier:	NCT00871715 History of Changes
Other Study ID Numbers:	U01-NS056256, CRC, NINDS
Study First Received:	March 27, 2009
Last Updated:	August 4, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Southern California:

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

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Brain Ischemia
Cerebrovascular Disorders
Infarction
Ischemia
Brain Infarction

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on February 02, 2012