Peperoni Emanuele, Trigili Emilio, Capotorti Eugenio, Capitani Stefano Laszlo, Fiumalbi Tommaso, Pettinelli Foebe, Grandi Sara, Rapalli Alberto, Lentini Giulia, Creatini Ilaria, Vitiello Nicola, Taglione Elisa, Crea Simona
The BioRobotics Institute, Scuola Superiore Sant'Anna, Pontedera, Pisa, Italy.
Department of Excellence in Robotics & AI, Scuola Superiore Sant'Anna, Pisa, Italy.
J Neuroeng Rehabil. 2024 Dec 19;21(1):214. doi: 10.1186/s12984-024-01511-w.
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.
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.
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.
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.
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 .
在创伤后手部康复的背景下，手部关节僵硬会限制关节活动范围（ROM）、握力以及进行简单抓握动作的可能性。机器人康复已被广泛应用于神经科患者的手部治疗，但其在骨科领域的应用仍然有限。本文介绍了一项针对该人群的初步研究，该研究使用一种动力手指外骨骼设备，即I-Phlex进行康复治疗。该设备旨在使掌指关节（MCP）在屈伸运动中活动起来。本研究的目的是验证I-Phlex在临床环境中的短期疗效、使用体验和安全性。作为次要目标，该研究验证了该设备测量临床相关变量的能力。
六名右手患有创伤相关疾病的受试者参与了实验。治疗师和外骨骼在疗程开始和结束时记录被动和主动关节活动范围（PROM和AROM）。通过专门设计的问卷和数字疼痛评分量表（NPRS）评估使用体验。通过计算手术期间不良事件的数量来评估安全性。
受试者的PROM和AROM中位数分别增加了5.88%和11.11%。问卷报告的中位数得分分别为93.83；四分位距（IQR）（85.01 - 100）和80.00；IQR（79.79 - 93.75）。治疗前后受试者的NPRS中位数没有增加。没有记录到对患者的重大不良事件或损伤。仅报告了一次因传输电缆制动导致的故障，但患者报告没有受伤或不适。使用外骨骼记录的ROM测量值与治疗师使用角度计测量的值之间未观察到统计学差异。
该设备及相关康复训练可成功用于MCP关节的临床康复。该设备的测量结果与治疗师使用角度计的评估结果一致。未来的研究旨在强化所获得的结果，引入对照组以确定该技术与传统疗法相比的具体贡献。
使用可穿戴机器人设备进行手部运动康复（WRL HX MCP），Clinicaltrials.gov标识符NCT05155670，注册日期2021年12月13日，网址https://clinicaltrials.gov/ct2/show/NCT05155670 。
