Trial Design
stroke
STROKE
This study was a single-site, single-blind randomized controlled trial comparing
home-based therapy with FitMi to conventional therapy for individuals in the
subacute phase of stroke. The study was performed at Rancho Los Amigos National
Rehabilitation Center in Downey, CA. Participants were invited for an initial
assessment to confirm they met the inclusion criteria and to establish baseline
measures. Participants provided informed written consent. Qualifying
participants were randomly assigned to either the FitMi group or the
conventional group. Participants in both groups were instructed to perform
self-guided therapy for at least 3 hours/week for 3 consecutive weeks. All
participants received weekly phone calls from a supervising therapist. After the
3-week exercise period, participants returned for an end-of-therapy assessment
and to return study materials. Participants returned 1 month later for a
follow-up assessment. The trial was pre-registered on ClinicalTrials.gov
(NCT03503617) and approved by the Rancho Research Institute, Inc. Institutional
Review Board at Rancho Los Amigos National Rehabilitation Center (IRB #263).