Arm Rehabilitation Study After Stroke "ICARE"

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Accelerated Skill Acquisition Program (ASAP) Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: ASAP
    Description: 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.
  • Dose-Equivalent Usual & Customary Care - DEUCC Behavioral
    Other Names: DEUCC
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: DEUCC
    Description: 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.
  • Usual and Customary Care - UCC Behavioral
    Intervention Desc: 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.
  • Usual and Customary Care - UCC Behavioral
    Other Names: UCC
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: UCC
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of three arms: 1. Accelerated Skill Acquisition Program (ASAP), 2. Dose-Equivalent Usual & Customary Care - DEUCC, and 3. Usual and Customary Care - UCC. These all call for 1 hour of therapy 3 times per week over 10 weeks. All patients then will get follow-up at one year using Wolf Motor Function Test(time measures), Stroke Impact Scale, NIHSS, Arm Muscle Torque Test, Wolf Motor Function Test (WMFT) (strength components), Upper Extremity Fugl Meyer (UEFM), Motor Component; Patient Health Questionnaire 9 (PHQ-9), As-Tex Sensory Index, Motor Activity Log 28 QOM (MAL-28), Satisfaction with Life Scale (SWLS), Reintegration to Normal Living Index (RNLI), Single-Item Subjective Quality of Life Measurement (SQOL), EQ5D, Confidence in Arm & Hand Movement (CAHM); Cognitive Battery (7-item): Short Blessed Memory Orientation Concentration Test, D-KEFS Verbal Fluency Test/Animal Naming, HTLV-Total and Delay Recall, Color Trail-Making Tests A & B, WMS-III Digit Span Backward, &Neuropsychiatric Inventory Questionnaire.

Outcomes

Type Measure Time Frame Safety Issue
Primary Wolf Motor Function Test (WMFT) time measures: determines the time required to perform 15 standardized tasks with each upper extremity; Stroke Impact Scale (SIS)- assesses changes in impairments, disabilities and handicaps following a stroke.
Secondary National Institute of Health Stroke Scale (NIHSS); Arm Muscle Torque Test; Wolf Motor Function Test (WMFT) strength components; Upper Extremity Fugl Meyer (UEFM), Motor Component; Patient Health Questionnaire 9 (PHQ-9); As-Tex Sensory Index; Motor Activity Log 28 QOM (MAL-28); Satisfaction with Life Scale (SWLS); Reintegration to Normal Living Index (RNLI); Single-Item Subjective Quality of Life Measurement (SQOL); EQ5D; Confidence in Arm & Hand Movement (CAHM); Cognitive Battery (7-item): Short Blessed Memory Orientation Concentration Test, D-KEFS Verbal Fluency Test/Animal Naming, HTLV-Total and Delay Recall, Color Trail-Making Tests A & B, WMS-III Digit Span Backward, Neuropsychiatric Inventory Questionnaire.
Primary Wolf Motor Function Test (WMFT) time measures: determines the time required to perform 15 standardized tasks with each upper extremity. 1 year post-randomization No
Primary Stroke Impact Scale (SIS)- assesses changes in impairments, disabilities and handicaps following a stroke. 1 year post-randomization No
Secondary National Institute of Health Stroke Scale (NIHSS) 1 year post-randomization No
Secondary Arm Muscle Torque Test 1 year post-randomization No
Secondary Wolf Motor Function Test (WMFT) strength components 1 year post-randomization No
Secondary Upper Extremity Fugl Meyer (UEFM), Motor Component 1 year post-randomization No
Secondary Patient Health Questionnaire 9 (PHQ-9) 1 year post-randomization No
Secondary As-Tex Sensory Index 1 year post-randomization No
Secondary Motor Activity Log 28 QOM (MAL-28) 1 year post-randomization No
Secondary Satisfaction with Life Scale (SWLS) 1 year post-randomization No
Secondary Reintegration to Normal Living Index (RNLI) 1 year post-randomization No
Secondary Single-Item Subjective Quality of Life Measurement (SQOL) 1 year post-randomization No
Secondary EQ5D 1 year post-randomization No
Secondary Confidence in Arm & Hand Movement (CAHM) 1 year post-randomization No
Secondary Short Blessed Memory Test 1 year post-randomization No
Secondary D-KEFS Verbal Fluency Test 1 year post-randomization No
Secondary Hopkins Verbal Learning Test, Revised (HVLT-R) 1 year post-randomization No
Secondary Digits Span Backward 1 year post-randomization No
Secondary Color Trails Making Tests 1 & 2 1 year post-randomization No
Secondary Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) 1 year post-randomization No
Primary Wolf Motor Function Test (WMFT) Log-transformed Time Baseline to 1 year post-randomization No
Primary Wolf Motor Function Test Time Baseline to 1 year post-randomization No
Primary Stroke Impact Scale (SIS) Hand Function Subscale Score. Baseline to 1 year post-randomization No
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) Baseline to 1 year post-randomization No

Sponsors