Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT05369533
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.
Study:
NCT05369533
Study Brief:
Protocol Section:
NCT05369533