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Background: In the context of post-traumatic hand rehabilitation, stiffness of the hand joints limits the range of motion (ROM), grip strength, and the possibility of performing simple grasps. Robotic rehabilitation has been widely adopted for hand treatment with neurological patients, but its application in the orthopaedic scenario remains limited. In this paper, a pilot study targeting this population is presented, where the rehabilitation is performed using a powered finger exoskeleton, namely I-Phlex. The device aims to mobilize the metacarpal-phalangeal joint (MCP) in flexion-extension movements. The objective of the study was to verify the short-term efficacy, experience of use, and safety of I-Phlex in a clinical setting. As a secondary objective, the study verified the device's capability to measure clinically relevant variables.
Methods: Six subjects with trauma-related illnesses of the right hand took part in the experiment. Passive and active range of motion (PROM and AROM) were recorded at the beginning and the end of the session by the therapist and by the exoskeleton. Experience of use was assessed through ad-hoc questionnaires and a numerical pain rate scale (NPRS). Safety was assessed by computing the number of adverse events during the operation.
Results: Median increases in the PROM and AROM of 5.88% and 11.11% respectively were recorded among subjects. The questionnaires reported a median score of 93.83; IQR (85.01-100) and 80.00; IQR (79.79-93.75) respectively. No increase in the median NPRS was recorded among subjects between pre-and post-treatment. No major adverse event or injury to the patients was recorded. Only one malfunction was reported due to the brake of a transmission cable, but the patient reported no injury or discomfort. No statistical significance was observed between the ROM measurement recorded using the exoskeleton and the ones taken by the therapist using the goniometer.
Conclusions: The device and related rehabilitation exercises can be successfully used in the clinical rehabilitation of the MCP joint. The device measurements are in line with the goniometer assessment from the therapist. Future studies will aim to reinforce the results obtained, introducing a control group to conclude on the specific contribution of the technology compared to conventional therapy.
Trial Registration: Hand Motor Rehabilitation Using a Wearable Robotic Device (WRL HX MCP), Clinicaltrials.gov ID NCT05155670, Registration date 13 December 2021, URL https://clinicaltrials.gov/ct2/show/NCT05155670 .
