StrokeICARENCT00871715
Arm Rehabilitation Study After Stroke
A study testing Accelerated Skill Acquisition Program (ASAP), Dose-Equivalent Usual & Customary Care - DEUCC and Usual and Customary Care - UCC in people with Stroke and Brain Infarction, run by University of Southern California at 8 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Brain Infarction, Brain Ischemia
- What is being tested?
- Accelerated Skill Acquisition Program (ASAP), Dose-Equivalent Usual & Customary Care - DEUCC and Usual and Customary Care - UCC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2009to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University
Atlanta, Georgia, 30322
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Rancho Los Amigos National Rehabilitation Center
Los Angeles, California, 90242
Long Beach Memorial Medical Center
Los Angeles, California, 90806
Huntington Rehabilitation Medicine Associates
Los Angeles, California, 91105
Casa Colina Centers for Rehabilitation
Los Angeles, California, 91769
National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative
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.
Read the 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.
- Being tested
- Accelerated Skill Acquisition Program (ASAP), Dose-Equivalent Usual & Customary Care - DEUCC, Usual and Customary Care - UCC
- 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
- Medical subject headings
- Stroke, Brain Infarction, Brain Ischemia, Cerebral Infarction, Cerebrovascular Disorders, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Skill Acquisition Program (ASAP)Behavioural
Also called 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 - DEUCCBehavioural
Also called 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 - UCCBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Usual and Customary Care - UCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 1 year post-randomization
Secondary outcomes (28)
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
As-Tex Sensory Index
Measured: Baseline to 1 year post-randomization
Upper Extremity Fugl Meyer (UEFM), Motor Component
Measured: Baseline to 1 year post-randomization
D-KEFS Verbal Fluency Test
Measured: Baseline to 1 year post-randomization
Digits Span Backward
Measured: Baseline to 1 year post-randomization
Hopkins Verbal Learning Test, Revised (HVLT-R)
Measured: Baseline to 1 year post-randomization
Color Trails Making Tests 1 & 2
Measured: Baseline to 1 year post-randomization
Short Blessed Memory Test
Measured: Baseline to 1 year post-randomization
Patient Health Questionnaire 9 (PHQ-9)
Measured: Baseline to 1 year post-randomization
Confidence in Arm & Hand Movement (CAHM)
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
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.
Measured: Baseline to 1 year post-randomization
Motor Activity Log 28 QOM (MAL-28)
Measured: Baseline to 1 year post-randomization
EQ5D
Measured: Baseline to 1 year post-randomization
Satisfaction With Life Scale (SWLS)
Measured: Baseline to 1 year post-randomization
Single-Item Subjective Quality of Life Measurement (SQOL)
Measured: Baseline to 1 year post-randomization
Reintegration to Normal Living Index (RNLI)
Measured: Baseline to 1 year post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Carolee Winstein, University of Southern California
- Investigators
- Carolee J. Winstein, PhD, PT, Principal investigator, University of Southern CaliforniaAlexander Dromerick, MD, Principal investigator, MedStar National Rehabilitation NetworkSteven Wolf, PhD, PT, Principal investigator, Emory UniversityMonica A Nelsen, DPT, PT, Study director, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871715
- Sponsor's protocol ID
- U01NS056256
- Other IDs
- U01NS056256
- Acronym
- ICARE
- Status last verified
- Jun 2019
- First submitted
- 27 Mar 2009
- Last updated
- 9 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23311856Duff 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.
PubMed 25323459Winstein 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.
PubMed 26864411Martinez 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.
PubMed 32433993Lewthwaite 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.
PubMed 29554849Rowe 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.
PubMed 28434819
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative
- ClinicalTrials.gov ID
- NCT00871715
- Acronym / sponsor ID
- ICARE / U01NS056256
- Keywords
- stroke, hemiparesis, physical therapy, occupational therapy, neurorehabilitation, patient focused, motor learning, motor control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 27 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASAP | Experimental | Behavioral: Accelerated Skill Acquisition Program (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. |
| DEUCC | Active comparator | Behavioral: Dose-Equivalent Usual & Customary Care - DEUCCDose-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. |
| UCC | Other | Behavioral: Usual and Customary Care - UCCUsual 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Skill Acquisition Program (ASAP)Also: ASAPA 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. | Behavioural | ASAP |
| Dose-Equivalent Usual & Customary Care - DEUCCAlso: DEUCCUsual 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. | Behavioural | DEUCC |
| Usual and Customary Care - UCCAlso: UCCUsual 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. | Behavioural | UCC |
Primary outcome
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.
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.
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.
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.
28 secondary outcomes
Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)
Time frame: Baseline to 1 year post-randomization
Stroke Impact Scale (SIS) Mobility Subscale Score.
Time frame: Baseline to 1 year post-randomization
Stroke Impact Scale (SIS) ADL/IADL Subscale Score.
Time frame: Baseline to 1 year post-randomization
National Institute of Health Stroke Scale (NIHSS)
Time frame: Baseline to 1 year post-randomization
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 #14 Grip Strength
Time frame: Baseline to 1 year post-randomization
Arm Muscle Torque Test - Elbow Extensors
Time frame: Baseline to 1 year post-randomization
Arm Muscle Torque Test - Elbow Flexors
Time frame: Baseline to 1 year post-randomization
Arm Muscle Torque Test - Shoulder Extensors
Time frame: Baseline to 1 year post-randomization
Arm Muscle Torque Test - Shoulder Flexors
Time frame: Baseline to 1 year post-randomization
Arm Muscle Torque Test - Wrist Extensors
Time frame: Baseline to 1 year post-randomization
Arm Muscle Torque Test - Wrist Flexors
Time frame: Baseline to 1 year post-randomization
As-Tex Sensory Index
Time frame: Baseline to 1 year post-randomization
Upper Extremity Fugl Meyer (UEFM), Motor Component
Time frame: Baseline to 1 year post-randomization
D-KEFS Verbal Fluency Test
Time frame: Baseline to 1 year post-randomization
Digits Span Backward
Time frame: Baseline to 1 year post-randomization
Hopkins Verbal Learning Test, Revised (HVLT-R)
Time frame: Baseline to 1 year post-randomization
Color Trails Making Tests 1 & 2
Time frame: Baseline to 1 year post-randomization
Short Blessed Memory Test
Time frame: Baseline to 1 year post-randomization
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline to 1 year post-randomization
Confidence in Arm & Hand Movement (CAHM)
Time frame: Baseline to 1 year post-randomization
Stroke Impact Scale (SIS) Communication Subscale Score.
Time frame: Baseline to 1 year post-randomization
Stroke Impact Scale (SIS) Emotion Subscale Score.
Time frame: Baseline to 1 year post-randomization
Motor Activity Log 28 QOM (MAL-28)
Time frame: Baseline to 1 year post-randomization
EQ5D
Time frame: Baseline to 1 year post-randomization
Satisfaction With Life Scale (SWLS)
Time frame: Baseline to 1 year post-randomization
Single-Item Subjective Quality of Life Measurement (SQOL)
Time frame: Baseline to 1 year post-randomization
Reintegration to Normal Living Index (RNLI)
Time frame: Baseline to 1 year post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23311856Winstein 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.
- Background: PubMed 25323459Duff 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.
- Results publication: PubMed 26864411Winstein 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.
- Derived from this study: PubMed 32433993Martinez 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.
- Derived from this study: PubMed 29554849Lewthwaite 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.
- Derived from this study: PubMed 28434819Rowe 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.
- ICARE Administrative Headquarters: USC Department of Biokinesiology \& Physical TherapyLink provided by the sponsor.
- ICARE Clinical Site: Casa Colina Rehabilitation CentersLink provided by the sponsor.
- ICARE Clinical Center: National Rehabilitation HospitalLink provided by the sponsor.
- ICARE Clinical Site: Huntington Rehabilitation Medical AssociatesLink provided by the sponsor.
- ICARE Clinical Site: Rancho Los Amigos National Rehabilitation CenterLink provided by the sponsor.
- ICARE Clinical Center: Emory UniversityLink provided by the sponsor.
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Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolee J. Winstein, PhD, PT principal investigator
University of Southern California
Alexander Dromerick, MD principal investigator
MedStar National Rehabilitation Network
Steven Wolf, PhD, PT principal investigator
Emory University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Skill Acquisition Program (ASAP), Dose-Equivalent Usual & Customary Care - DEUCC and Usual and Customary Care - UCC in people with Stroke and Brain Infarction, run by University of Southern California at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (WMFT) Log-transformed Time (time frame: Baseline to 1 year post-randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871715, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.