Accepted for/Published in: JMIR Rehabilitation and Assistive Technologies
Date Submitted: Jun 4, 2024
Date Accepted: Nov 27, 2024
Effectiveness of a new device for hand, wrist, and forearm rehabilitation: A Feasibility Randomized Controlled Trial
ABSTRACT
Background:
Forearm, wrist, and hand impairments affect many individuals and impose a significant economic burden on healthcare systems. The FEPSimTM (flexion, extension, pronation, and supination) is designed for hand and wrist rehabilitation. It could become part of the standard care for upper extremity rehabilitation, aiming to improve range of motion, dexterity, and strength during therapeutic activities. However, the FEPSimTM has not yet been tested in a healthcare setting, highlighting the need for a trial to assess its effectiveness in upper extremity rehabilitation.
Objective:
To assess the feasibility of conducting a definitive trial investigating the effectiveness of adding a new device for hand therapy exercises, the FEPSim, to standard care for patients with impairments of the hand, wrist, and forearm.
Methods:
Thirty-eight patients with impairments of distal upper extremity were randomly assigned to either the intervention group (FEPSim and standard care, n = 19) or to the control group (standard care, n = 19). Therapeutic activities to increase strength, range of motion, resistance, and dexterity were delivered using the FEPSim device for the intervention group. Outcome measures included wrist passive and active range of motion, grip strength, pinch grip force, and Patient Rated Wrist Evaluation.
Results:
The trial retention rate and compliance were high (94.73% and 94.96%, respectively). The comparisons between groups of the change-from-baseline revealed that in 63.2% (12/19) of the outcome variables, the change was in favor of the FEPSim, with statistically significant improvements in passive wrist flexion (t(34)=-0.335, p=0.008) and grip strength (t(34)=-1.841, p=0.037).
Conclusions:
The FEPSim was accepted as part of standard care by therapists and patients at two hospitals. The trial design was feasible for hand intervention using the FEPSim device. The FEPSim positively affected grip strength, an objective measure of hand functioning. Clinical Trial: Name of the trial registry: ISRCTN Registration number: ISRCTN13656014 URL of the registry: https://doi.org/10.1186/ISRCTN13656014
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