Dose Optimization for Stroke Evaluation "DOSE"

Completed

Phase 1 Results N/A

Trial Description

This study is about rehabilitation of arm function after a stroke. The investigators are testing the dosage of therapy that is needed for meaningful recovery of arm and hand function. Dosage of therapy refers to the amount of time (in this case, the total number of hours) that a person participates in treatment. The investigators hope to learn how much therapy time is needed in order for change to occur in arm and hand function after a person has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or hand at least 6 months ago.

Conditions

Interventions

  • Accelerated Skill Acquisition Program (ASAP) Behavioral
    Intervention Desc: A focused, intense, evidence-based, upper extremity rehabilitation program. 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 Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit.
    ARM 1: Kind: Experimental
    Label: High Therapy Dose
    Description: Sixty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
    ARM 2: Kind: Experimental
    Label: Moderate Therapy Dose
    Description: Thirty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
    ARM 3: Kind: Experimental
    Label: Low Therapy Dose
    Description: Fifteen total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
  • Active Monitoring Behavioral
    Intervention Desc: This is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice.
    ARM 1: Kind: Experimental
    Label: Active Monitoring
    Description: This is an observation only group.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Bilateral Arm Reaching Test (BART) Change from Baseline to up to 4 months post-randomization No
Primary Wolf Motor Function Test (WMFT) Change from Baseline to up to 4 months post-randomization No
Primary Motor Activity Log (MAL) Change from Baseline to up to 4 months post-randomization No
Secondary Stroke Impact Scale (SIS) Change from Baseline to up to 4 months post-randomization No
Secondary Upper Extremity Fugl-Meyer (UEFM) Change from Baseline to up to 4 months post-randomization No

Sponsors