Effectiveness of a New Device for Hand, Wrist, and Forearm Rehabilitation: Feasibility Randomized Controlled Trial.
Adriana M Ríos Rincón, Christine Guptill, Yilina Liubaoerjijin and 4 others
PMID 39874189WHAT IT FOUND
Adding the FEPSim device to standard hand therapy improved grip strength and passive wrist flexion more than standard equipment alone.
However, patient-reported pain and disability did not show a difference between the groups. This small pilot trial suggests the device is feasible but requires a larger study to confirm its effectiveness.
Key findings
01The intervention group showed significantly greater improvements in grip strength and passive wrist flexion compared to the control group, but no significant difference was found in patient-reported pain or disability.
02The study was underpowered, with a small overall effect size, and the authors recommend a future definitive trial with 385 participants to properly assess effectiveness.
03The device was feasible to use, with high retention and compliance rates, and was incorporated into therapy sessions by both therapists and participants.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTs
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What it does not show
The study was a feasibility pilot with a small sample size (36 participants) and low statistical power, making it difficult to draw definitive conclusions about effectiveness. Missing baseline data for grip strength (19%) and passive range of motion (14%) was imputed, which may affect the reliability of the results for these specific outcomes. The trial was conducted during the COVID-19 pandemic, which impacted recruitment, service availability, and potentially the delivery of care. There was no long-term follow-up, so the durability of any gains cannot be determined. The primary outcome was not clearly distinguished from secondary outcomes in the reporting, and the positive findings were limited to two specific measures out of nineteen.
Declared interests
The device was developed by Karma Machining & Manufacturing Ltd. The paper does not explicitly state funding sources or author conflicts of interest in the provided text, but the manufacturer's involvement in development is noted.
The easy way to misread this
Do not assume the FEPSim device is more effective than standard hand therapy for improving patient-reported pain or disability. The significant improvements were limited to two objective physical measures (grip strength and passive wrist flexion) in a small, underpowered pilot study, while patient-centered outcomes showed no difference.