FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke
Phase: NA
Conditions: Cerebral Stroke
Sponsor: Flint Rehabilitation Devices, LLC

Study Protocol and Statistical Analysis Plan 
 
for 
 
FitMi Plus: Smart Functional Modules for Practicing Activities of Daily 
Living after Stroke 
 
ClinicalTrials.gov Identifier: NCT03935425 
 
Date: 12/31/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background 
 
Stroke is the leading cause of chronic disability in the United States, with over 700,000 people 
experiencing a new stroke each year. Other conditions that lead to chronic disability are spinal cord injury, 
hand and wrist trauma, multiple sclerosis, traumatic brain injury, muscular dystrophies, back injury, and 
cerebral palsy. In all these conditions the human motor system retains substantial capacity for plasticity, 
and thus intensive rehabilitation exercise can reduce long-term movement impairment. Unfortunately, 
access to intensive rehabilitation is limited due to cost and therapists’ time constraints, preventing many 
individuals from receiving the amount of therapy required to maximize their potential recovery. There has 
been a recent surge in the development of technologies, services, and methodologies for enabling 
individuals to practice on their own at home. However, existing technologies for home therapy have not 
been widely adopted in actual practice. The most common approach to home-based therapy is simply 
providing patients with printed sheets of exercises. This approach is not motivating, does little to 
incorporate current theories on effective rehabilitation, and is associated with low compliance and high 
dropout rates. 
Flint Rehab’s existing FitMi system has demonstrated success in motivating individuals with stroke 
to perform moderately intense therapy with relevant feedback, individually tailored exercises, and an 
appropriate challenge level. However, FitMi does not encourage the functional practice of activities of 
daily living. Recognizing this, we developed an expanded version of FitMi called FitMi Plus that combines 
objects commonly used during activities of daily living into distinct Functional Modules, allowing users to 
practice specific functional tasks while engaging with a motivating software platform. 
 
Trial Design 
 
This study was a double-site, single-blind randomized controlled trial evaluating the efficacy of home-
based functional training with FitMi Plus compared to non-functional exercise (FitMi Basic) with 
individuals with chronic stroke (N=50). This randomized controlled trial was carried out at two separate 
study sites: the University of California, Irvine, and Rancho Los Amigos National Rehabilitation Center in 
Downey, CA, with the specific objective of enrolling 25 participants at each study site by the end of the 
project period. 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 Plus group or non-functional 
exercise (FitMi Basic) group. Participants in both groups were instructed to perform self-guided 
therapy for at least 3 hours/week for three consecutive weeks. Appropriate exercise movements for each 
participant were selected in collaboration with each participant by a trained therapist. 
After the three-week exercise period, participants returned for a post-therapy assessment. At this 
assessment, participants returned their devices. Participants also returned one month later for a one-
month follow-up assessment. The trial was pre-registered on ClinicalTrials.gov (NCT03935425) and 
approved by the Rancho Research Institute, Inc. Institutional Review Board at Rancho Los Amigos National 
Rehabilitation Center and University of California, Irvine Institutional Review Board. 
 
 
Participants 
 
Inclusion criteria included experiencing one or more strokes >6 months prior, Upper Extremity Fugl-
Meyer (FM) Score >=15 and <=55 out of 66, absence of moderate to severe upper extremity pain (<= 4 on 
the 10 point visual-analog pain scale), ability to understand the instructions to operate FitMi, and age <= 
85 (as older age could be a confounding variable). Exclusion criteria included having other concurrent 

severe medical problems, visual deficits, severe neglect or apraxia, or enrollment in other therapy studies. 
After obtaining consent, participants received a 30-minute training session on how to set up and use their 
device to perform a prescribed list of exercises. Recruitment aimed to balance the age, ethnicity, and 
gender of the study participants to be representative of Los Angeles and Orange County in California, USA. 
All participants provided informed consent. 
Using an estimated effect size (Cohen’s d) of 0.9 based on long-term follow-up data from a previous 
study (N=18) of functionally oriented home-based exercise with MusicGlove, 22 participants in each group 
would provide a 90% chance of detecting a significant difference between groups at the 0.05 significance 
level (one-tailed t-test). To account for 10% dropout, we will recruit 25 participants in each group. 
Adaptive randomization was used to ensure matched levels of impairment between the FitMi Plus 
and FitMi Basic groups. Specifically, subjects were stratified by their UE FM Score into two levels (i.e. 15-
35, 36-55) and then randomized by alternating block allocation.  
 
Intervention 
 
Participants randomized to the FitMi Plus group were given a FitMi Plus system with custom 10” 
touchscreen tablet. Participants randomized to the FitMi Basic group were given a FitMi Basic system with 
custom 10” touchscreen tablet. For both groups, a supervising rehabilitation therapist selected the 
exercises for each participant based on their specific impairments and functional goals. All participants 
received 30 minutes of training from the therapist on how to perform the selected exercises correctly.  
Participants in both groups were instructed to perform self-guided therapy for at least 3 hours/week 
for three consecutive weeks. After the 3-week exercise period, participants returned for an end-of-
therapy assessment. At this assessment, participants returned their FitMi Plus or FitMi Basic systems. 
Participants returned one month later for a follow-up assessment. 
 
Outcomes 
 
The primary outcome measure was the change in Motor Activity Log (MAL) score from baseline to 
one-month post-therapy to assess increases in self-reported functional use of the upper extremity. MAL 
was assessed at baseline and one-month follow-up. The secondary outcome measure was the change in 
Upper Extremity Fugl-Meyer (FM) Score from baseline to one-month post-therapy to assess changes in 
motor impairment. These measures are widely used in stroke rehabilitation research and have good 
sensitivity and reliability. All assessments were performed by a blinded, trained evaluator. 
 
 
Statistical Methods 
 
Statistical analyses were performed using Matlab R2020 software. Change in Motor Activity Log (MAL) 
from baseline assessment to one-month follow-up was compared between FitMi Plus group and FitMi 
Basic group using an unpaired two-tailed t-test. We recruited 50 total participants across both study sites. 
Two participant did not return for long term follow-up and were excluded from final analysis, leading to a 
final n=48 (13 female, 35 male), with 24 participants in the FitMi Plus group and 24 participants in the 
FitMi Basic group. Similarly, change in Upper Extremity Fugl-Meyer Score from baseline to one-month 
post-therapy was compared between groups using an unpaired two-tailed t-test.