To assess the effectiveness of an intensive, functional, gamified rehabilitation program using the ArmAble™ device in improving UL motor function and quality of life in people with acute and sub-acute stroke.
In this single-blind, multi-centric, randomized clinical trial (CTRI/2020/09/027651), 120 adults with acute or sub-acute unilateral stroke were randomized to receive either task-based training [comparator group (n=56)] or gamified training (n=64) using the ArmAbleTM [experimental group (EG)] in addition to conventional therapy for two hours/day, six days/week for two weeks. This was followed by a home-based, functional rehabilitation program for an additional four weeks (~30 minutes/day, six days/week). Primary outcomes comprised the Fugl-Meyer assessment–upper extremity (FMA-UE) and action research arm test (ARAT) which were assessed by a blinded assessor at the baseline, two, and six weeks after the intervention. The secondary outcomes were the quality of life assessed with stroke impact scale-version 3.0 (SIS V3.0), the performance of activities of daily living as measured by the modified Rankin scale (mRS), and UL strength evaluated with the motricity index (MI). A linear mixed-effect regression model was employed for statistical analysis.
The mean (SD) age of the participants was 54.4 (±11.7) years (78.1% men) in the EG and 57.7 (±10.9) years (73.2% men) in the CG. The median (IQR) time since stroke was 30.0 (54.0) days in the EG and 22.5 (45.0) days in the CG. Following the two-week intervention, a statistically significant improvement was observed in the EG for the FMA-UE [between-group mean differences (95% CI): -3.9 (-6.5, -1.3); p=.003]; but not for the ARAT [-2.9 (-5.8, 0.0); p=.051]. Gains in six weeks were significantly greater in the EG for both FMA-UE [-3.9 (-6.5, -1.3); p=.003]; and ARAT [-3.0 (-5.9, -0.0); p=.046]. Although the change from baseline scores for the SIS V3.0, mRS, and MI was higher in EG than in CG, the differences were not statistically significant.
Early game-based rehabilitation with the ArmAble™ device has shown statistically and clinically significant improvement in UL function (FMA-UE and ARAT) following acute and sub-acute stroke. Future studies administering the intervention over an extended period may yield better results on the performance of activities of daily living and quality-of-life outcomes.
Intensive, functional gamified rehabilitation provided through the ArmAble™ can be used from the early stages of stroke recovery to make the therapy more intensive, repetitive, motivating, and fun-based, thereby improving the upper limb motor function.
Hemiparesis
Upper extremity
