Telerehabilitation for Stroke

(TR-2 Trial)

Recruiting at 9 trial locations

Overseen By Steven Cramer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Botulinum toxin

Disqualifiers: Neurological, Psychiatric, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 40

Duration: 6 weeks

202 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone.

Patients with arm weakness due to stroke that happened in the past 90-150 days will be randomized into one of two groups: \[1\] TR and usual care; \[2\] usual care only (no TR), but people in the usual care 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.

Who Is on the Research Team?

Steven Cramer, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for individuals who had a stroke 90-150 days ago, resulting in arm weakness. They must be able to follow simple commands and perform basic rehabilitation exercises. Participants need an Action Research Arm Test score of 18-44 and should move at least one block using the affected arm in a Box & Block Test within 60 seconds.

Inclusion Criteria

My arm's movement is limited due to a stroke.

I can do all 3 rehab exercises as shown at my first visit.

My stroke was confirmed by imaging 90 to 150 days ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telerehabilitation targeting arm function, consisting of 70 minutes/day of activities, 6 days a week for 6 weeks

6 weeks

36 sessions (half supervised, half independent)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of arm function and a single MRI scan

2 months

4 visits (in-person)

Open-label extension (optional)

Participants in the usual care group are offered telerehabilitation after the study is completed

What Are the Treatments Tested in This Trial?

Interventions

• Telerehabilitation

Trial Overview The study is testing if telerehabilitation (TR) targeting arm movement plus usual care improves arm function after stroke better than usual care alone. TR involves daily activities for the arms, done at home for six weeks, with sessions lasting about 70 minutes each day.

How Is the Trial Designed?

Group I: Telerehabilitation + Usual Care Experimental Treatment 1 Intervention

Patients will receive 36 telerehabilitation sessions targeting arm motor function in addition to their usual care. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently.

Group II: Usual Care Active Control 1 Intervention

Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team. All participants in this group will be offered TR at the end of the study.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Moss Rehabilitation Research Institute

Collaborator

Trials

12

Recruited

10,100+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+