Dose Optimization for Stroke Evaluation (DOSE)

University of Southern California

Status and phase: Completed; Phase 1

Conditions: Infarction; Brain Ischemia; Stroke; Cerebrovascular Disorders

Treatments: Behavioral: Accelerated Skill Acquisition Program (ASAP); Behavioral: Active Monitoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01749358

R01HD065438 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic or hemorrhagic stroke that occured at least 6 months ago.
• At least 21 years of age
• Persistent arm and hand weakness, with some ability to release a grasp
• Able to provide consent to participate
• No history of a medical condition that limited arm or hand use prior to the stroke
• Medically stable
• Able to participate for 10 months and attend evaluations at the University of Southern California (USC) Health Sciences Campus.
• Able to communicate in English or Spanish.

Exclusion criteria

• Severe upper extremity sensory impairment
• Neglect
• Current major depressive disorder
• Severe arthritis or orthopedic problems that limit arm or hand movement
• Pain that interferes with daily activities
• Currently enrolled in other rehabilitation or drug intervention studies
• Living too far from the training site to participate reliably
• Receiving oral or injected anti-spasticity medications during study treatment.
• Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

High Therapy Dose

Experimental group

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).

Treatment:

Behavioral: Accelerated Skill Acquisition Program (ASAP)

Moderate Therapy Dose

Experimental group

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).

Treatment:

Behavioral: Accelerated Skill Acquisition Program (ASAP)

Low Therapy Dose

Experimental group

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).

Treatment:

Behavioral: Accelerated Skill Acquisition Program (ASAP)

Active Monitoring

Other group

Description:

This is an observation only group.

Treatment:

Behavioral: Active Monitoring