Arm Rehabilitation Study After Stroke

Stroke Clinical Trial

— ICARE  

Official title:

Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871715
• Other study ID #: U01NS056256
• Secondary ID: U01NS056256
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: February 2014

Study information

• Verified date: June 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Infarction
• Brain Ischemia
• Cerebral Infarction
• Cerebrovascular Disorders
• Infarction
• Ischemia
• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Casa Colina Centers for Rehabilitation	Los Angeles	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Huntington Rehabilitation Medicine Associates	Los Angeles	California
United States	Long Beach Memorial Medical Center	Los Angeles	California
United States	Rancho Los Amigos National Rehabilitation Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	National Rehabilitation Hospital	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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 F — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Monthly Telephone Interviews	A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.	monthly, beginning 30 days post-randomization
Other	Post-Intervention Interview	A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.	16-20 weeks post-randomization
Other	Exit Interview	A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.	Post-intervention to 1 year post-randomization
Primary	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
Primary	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
Primary	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
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)	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	Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)	Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale.	Baseline to 1 year post-randomization
Secondary	Stroke Impact Scale (SIS) Mobility 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 mobility.	Baseline to 1 year post-randomization
Secondary	Stroke Impact Scale (SIS) ADL/IADL 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 ease with activities queried.	Baseline to 1 year post-randomization
Secondary	National Institute of Health Stroke Scale (NIHSS)	Change from baseline to end-of-study (12 months post-randomization) in National Institute of Health Stroke Scale (NIHSS). Range 0-2. Lower scores indicate less stroke severity.	Baseline to 1 year post-randomization
Secondary	Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box	Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds.	Baseline to 1 year post-randomization
Secondary	Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength	Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization.	Baseline to 1 year post-randomization
Secondary	Arm Muscle Torque Test - Elbow Extensors	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions.Positive values indicate a strength gain.	Baseline to 1 year post-randomization
Secondary	Arm Muscle Torque Test - Elbow Flexors	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.	Baseline to 1 year post-randomization
Secondary	Arm Muscle Torque Test - Shoulder Extensors	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.	Baseline to 1 year post-randomization
Secondary	Arm Muscle Torque Test - Shoulder Flexors	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.	Baseline to 1 year post-randomization
Secondary	Arm Muscle Torque Test - Wrist Extensors	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.	Baseline to 1 year post-randomization
Secondary	Arm Muscle Torque Test - Wrist Flexors	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.	Baseline to 1 year post-randomization
Secondary	As-Tex Sensory Index		Baseline to 1 year post-randomization
Secondary	Upper Extremity Fugl Meyer (UEFM), Motor Component		Baseline to 1 year post-randomization
Secondary	D-KEFS Verbal Fluency Test		Baseline to 1 year post-randomization
Secondary	Digits Span Backward		Baseline to 1 year post-randomization
Secondary	Hopkins Verbal Learning Test, Revised (HVLT-R)		Baseline to 1 year post-randomization
Secondary	Color Trails Making Tests 1 & 2		Baseline to 1 year post-randomization
Secondary	Short Blessed Memory Test		Baseline to 1 year post-randomization
Secondary	Patient Health Questionnaire 9 (PHQ-9)		Baseline to 1 year post-randomization
Secondary	Confidence in Arm & Hand Movement (CAHM)		Baseline to 1 year post-randomization
Secondary	Stroke Impact Scale (SIS) Communication 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 perceptions of ability to communicate and comprehend.	Baseline to 1 year post-randomization
Secondary	Stroke Impact Scale (SIS) Emotion 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 perceptions of mood and emotional control.	Baseline to 1 year post-randomization
Secondary	Motor Activity Log 28 QOM (MAL-28)		Baseline to 1 year post-randomization
Secondary	EQ5D		Baseline to 1 year post-randomization
Secondary	Satisfaction With Life Scale (SWLS)		Baseline to 1 year post-randomization
Secondary	Single-Item Subjective Quality of Life Measurement (SQOL)		Baseline to 1 year post-randomization
Secondary	Reintegration to Normal Living Index (RNLI)		Baseline to 1 year post-randomization

External Links

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