Hand Motor Rehabilitation Using a Wearable Robotic Device (WRL HX MCP): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Feasibility indicator: completion of study procedures
研究概览
简要总结
The purpose of this pilot study is to assess the safety and usability of the WRL HX MCP medical device, a prototypal robotic system for metacarpophalangeal joint mobilization. WRL HX MCP was developed by the Wearable Robotics Laboratory of Scuola Superiore Sant'Anna in a project funded by and in collaboration with INAIL, to fulfil the needs of patients with post-traumatic hand stiffness.
详细描述
This study aims to:
- Test the safety and reliability of the WRL HX MCP device for assisting flexion and extension movement of the stiff metacarpophalangeal joint
- Conduct a preliminary examination of the efficacy of the device in the treatment of joint stiffness to design a subsequent RCT
- Evaluate the performance of the device in estimating the biomechanical parameters useful for the objective treatment outcome assessment.
Ten injured workers with post-traumatic and/or post-operative index finger MCP stiffness will be enrolled in a clinical trial consisting of one to four sessions of robotic therapy with WRL HX MCP at the INAIL Rehabilitation Center in Volterra.
Pilot testing of the experimental device will include the preliminary goniometric measure of passive and active MCP range of motion (ROM), the selection of the appropriate size of exoskeleton segments to fit user's anthropometry, the robotic assessment of ROM, force and torque trajectories of MCP joint, a program of robot-assisted passive and active MCF mobilization and a final clinical and robotic reassessment of joint ROM. The session will last about 1 hour and all exercises will be administered by a trained physical therapist supported by two members of the engineering team; pain level will be assessed at baseline and after each mobilization sequence; patient feedback will be recorded about the usability of the device in term of comfort, wearability, user safety, and overall satisfaction.
For Aim 1, the Safety and Reliability of the device will be evaluated in terms of the number of adverse events and malfunctions occurring during the study session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of traumatic hand injury or post-traumatic hand surgery
- •hand size allowing to achieve proper exoskeleton fit
- •NRS pain score in the 1-5 range
排除标准
- •cognitive or linguistic ability insufficient to understand instructions
- •cardiac implanted electronic devices
- •open skin at the level of the patient-device interface
- •absence of contraindications for finger joints mobilisation
- •current or prior history of malignancy
- •pregnancy or breast feeding
结局指标
主要结局
Feasibility indicator: completion of study procedures
时间窗: through study completion, an average of 1 year
Percent of participants for whom study procedures were completed successfully
Feasibility indicator: patient acceptability
时间窗: After the robotic therapy session; the total expected time for the session is about 90 minutes.
Clinician-generated questionnaire to investigate patients' impressions about the physical interaction with the robotic device
Feasibility indicator: reliability evaluated through the number of device malfunctions
时间窗: through study completion, an average of 1 year
The physiotherapist is required to report any malfunctions occurring during the study in regard to the use of WRL HX MCP
次要结局
- Goniometric measure of MCP Active Range of Motion (AROM)(at baseline and immediately after the robotic therapy session.)
- Goniometric measure of MCP Passive Range of Motion (PROM)(at baseline and immediately after the robotic therapy session)
- Robotic measure of MCP Active Range of Motion (AROM)(at baseline and immediately after the robotic therapy session)
- Robotic measure of MCP passive Range of Motion (PROM)(at baseline and immediately after the robotic therapy session)
- Robotic estimation of MCP joint flexion peak torque(during robot-in-charge mobilization sequences)
- Numeric Pain Rating Scale (NPRS)(at baseline and after each of the two series of joint mobilization exercises, lasting up to 30 minutes each.)
- Safety evaluated through the number of adverse events(through study completion, an average of 1 year)