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Completed

NCT Number: NCT00871715

Arm Rehabilitation Study After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Neurologic Manifestations Paresis Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Casa Colina Centers for Rehabilitation, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: 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.

Other names: UCC

Primary outcomes

  1. Wolf Motor Function Test (WMFT) Log-transformed Time

    Time frame: Baseline to 1 year post-randomization

    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.

  2. Wolf Motor Function Test Time

    Time frame: Baseline to 1 year post-randomization

    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.

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

    Time frame: Baseline to 1 year post-randomization

    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.

  4. 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)

    Time frame: Baseline to 1 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.

Secondary outcomes

  1. Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)

    Time frame: Baseline to 1 year post-randomization

    Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale.

  2. Stroke Impact Scale (SIS) Mobility Subscale Score.

    Time frame: Baseline to 1 year post-randomization

    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.

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

    Time frame: Baseline to 1 year post-randomization

    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.

  4. National Institute of Health Stroke Scale (NIHSS)

    Time frame: Baseline to 1 year post-randomization

    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.

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

    Time frame: Baseline to 1 year post-randomization

    Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds.

  6. Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength

    Time frame: Baseline to 1 year post-randomization

    Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization.

  7. Arm Muscle Torque Test - Elbow Extensors

    Time frame: Baseline to 1 year post-randomization

    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.

  8. Arm Muscle Torque Test - Elbow Flexors

    Time frame: Baseline to 1 year post-randomization

    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.

  9. Arm Muscle Torque Test - Shoulder Extensors

    Time frame: Baseline to 1 year post-randomization

    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.

  10. Arm Muscle Torque Test - Shoulder Flexors

    Time frame: Baseline to 1 year post-randomization

    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.

  11. Arm Muscle Torque Test - Wrist Extensors

    Time frame: Baseline to 1 year post-randomization

    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.

  12. Arm Muscle Torque Test - Wrist Flexors

    Time frame: Baseline to 1 year post-randomization

    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.

  13. As-Tex Sensory Index

    Time frame: Baseline to 1 year post-randomization

  14. Upper Extremity Fugl Meyer (UEFM), Motor Component

    Time frame: Baseline to 1 year post-randomization

  15. D-KEFS Verbal Fluency Test

    Time frame: Baseline to 1 year post-randomization

  16. Digits Span Backward

    Time frame: Baseline to 1 year post-randomization

  17. Hopkins Verbal Learning Test, Revised (HVLT-R)

    Time frame: Baseline to 1 year post-randomization

  18. Color Trails Making Tests 1 & 2

    Time frame: Baseline to 1 year post-randomization

  19. Short Blessed Memory Test

    Time frame: Baseline to 1 year post-randomization

  20. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: Baseline to 1 year post-randomization

  21. Confidence in Arm & Hand Movement (CAHM)

    Time frame: Baseline to 1 year post-randomization

  22. Stroke Impact Scale (SIS) Communication Subscale Score.

    Time frame: Baseline to 1 year post-randomization

    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.

  23. Stroke Impact Scale (SIS) Emotion Subscale Score.

    Time frame: Baseline to 1 year post-randomization

    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.

  24. Motor Activity Log 28 QOM (MAL-28)

    Time frame: Baseline to 1 year post-randomization

  25. EQ5D

    Time frame: Baseline to 1 year post-randomization

  26. Satisfaction With Life Scale (SWLS)

    Time frame: Baseline to 1 year post-randomization

  27. Single-Item Subjective Quality of Life Measurement (SQOL)

    Time frame: Baseline to 1 year post-randomization

  28. Reintegration to Normal Living Index (RNLI)

    Time frame: Baseline to 1 year post-randomization

Other outcomes

  1. Monthly Telephone Interviews

    Time frame: monthly, beginning 30 days post-randomization

    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.

  2. Post-Intervention Interview

    Time frame: 16-20 weeks post-randomization

    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.

  3. Exit Interview

    Time frame: Post-intervention to 1 year post-randomization

    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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative

Acronym: ICARE

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2009
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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