Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke

Phase 1

Completed

Conditions: Stroke

Interventions: Device: Telerehabilitation
Drug: Placebo
Drug: Sinemet Pill

Registration Number: NCT05369533

Lead Sponsor: University of California, Los Angeles

Brief Summary: This study explores the effects of telerehabilitation and a study medication on rehabilitation outcomes in patients with stroke resulting in arm weakness. Patients with arm weakness due to a stroke that happened in the past 30 days will be randomized into one of three groups: \[1\] TR and placebo (a sugar pill) on top of usual care; \[2\] TR and a medication (Sinemet 25/100) on top of usual care; \[3\] or usual care alone (no TR and no pill, but people in this group will be offered TR once the study is done). TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.

Detailed Description: This is a randomized, double-blind, placebo-controlled study that involves the use of telerehabilitation to deliver additional therapy for persons with stroke. Participants with arm weakness due to a stroke in the past 30 days will be randomized into one of three groups: (1) TR + Sinemet on top of usual care, (2) TR + placebo (sugar pill) on top of usual care, or (3) usual care only (no TR, no pill). The hypothesis of this study is patients receiving TR will have significantly greater recovery of arm function compared to patients receiving usual care. In addition, Sinemet is hypothesized to significantly enhancing this improvement.

Study participation will last up to 3 months and includes 4 in-person visits. At these visits, patients will undergo a battery of assessments including arm function, a single MRI scan of the brain, and blood draw for genotyping. Patients undergoing TR will receive arm motor training, which consists of 36 sessions of of assigned exercises, games, and stroke education; these are 70 minutes in length and take 6 days a week over 6-8 weeks. Subjects receiving TR will take a pill (Sinemet or placebo) prior to the TR training for the first 18 TR sessions; TR subjects will also continue usual care. Patients in the usual care group will not engage in TR or take a study pill, but will instead continue all of the therapies recommended by their medical team. At the end of the study, participants in the usual care group will be offered TR.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telerehabilitation + Placebo	Placebo	Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Placebo is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation + Sinemet	Telerehabilitation	Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Sinemet is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation + Placebo	Telerehabilitation	Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Placebo is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation + Sinemet	Sinemet Pill	Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Sinemet is taken one hour before starting TR, for the first 18 sessions.

Primary Outcome Measures

Name	Time	Method
Change in Action Research Arm Test Score From Baseline to 3 Months	Measured at baseline and 3 months later	Measures arm function using a scale that runs from 0 to 57 points, with higher scores indicating greater arm function.

Secondary Outcome Measures

Name	Time	Method
Change in Arm Motor Fugl-Meyer Scale From Baseline to 3 Months	Measured at baseline and 3 months later	Measures arm motor impairment using a scale that runs from 0 to 66 points, with higher scores indicating greater arm motor function (less impairment)