Hand Motor Rehabilitation Using a Wearable Robotic Device (WRL HX MCP)

Study Overview
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Brief Summary
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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.

Detailed Description
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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. For Aim 2, the efficacy of robot-assisted mobilization modes will be assessed by means of the longitudinal analysis of pre- and post-treatment measurements of MCP range of motion and pain intensity level, the flexion peak torque evaluation and the final administration of an ad-hoc satisfaction questionnaire. For aim 3, the performance of WRL HX MCP will be studied by comparing the robotic MCP angle estimation with the measurements from a motion capture system.

Official Title
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Hand Motor Rehabilitation Using a Wearable Robotic Device (WRL HX MCP): a Pilot Study

Conditions
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Hand Injuries

Intervention / Treatment
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* Device: WRL HX MCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic therapy<br>All participants will receive a program of robot-assisted rehabilitation exercises., including passive, active-assisive and active MCP Range-of-Motion Exercises, and active bidigital pinching movements in the transparent mode. | Device: WRL HX MCP<br>* WRL HX MCP is a non CE marked class IIa medical device designed for clinical application in hand rehabilitation; it consists in a cable-driven robotic MCP orthosis providing flexion-extension of the metacarpo-phalangeal joint. WRL HX MCP features and a series-elastic actuators (SEA) architecture for compliant actuation of MCP flexion-extension and a self-aligning mechanism to absorb human/robot joint axes misplacement. Exoskeleton module is mounted on a dorsal hand support and connected to its electronic box through wires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility indicator: completion of study procedures | Percent of participants for whom study procedures were completed successfully | through study completion, an average of 1 year | 
| Feasibility indicator: patient acceptability | Clinician-generated questionnaire to investigate patients' impressions about the physical interaction with the robotic device | After the robotic therapy session; the total expected time for the session is about 90 minutes. | 
| Feasibility indicator: reliability evaluated through the number of device malfunctions | The physiotherapist is required to report any malfunctions occurring during the study in regard to the use of WRL HX MCP | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goniometric measure of MCP Active Range of Motion (AROM) | The physiotherapist measures the MCP joint angles in maximum active flexion and extension using a short-arm goniometer | at baseline and immediately after the robotic therapy session. | 
| Goniometric measure of MCP Passive Range of Motion (PROM) | The physiotherapist measures the MCP joint angles in maximum passive flexion and extension using a short-arm goniometer | at baseline and immediately after the robotic therapy session | 
| Robotic measure of MCP Active Range of Motion (AROM) | MCP joint maximum active flexion and extension range of motion is registered while the device and human joint are coupled together, using WRL HX MCP set in a transparent mode as an evaluation tool, without any manual assistance. | at baseline and immediately after the robotic therapy session | 
| Robotic measure of MCP passive Range of Motion (PROM) | MCP joint maximum passive flexion and extension range of motion is registered while the device and human joint are coupled together, using WRL HX MCP set in a transparent mode as an evaluation tool, with manual assistance from the therapist. | at baseline and immediately after the robotic therapy session | 
| Robotic estimation of MCP joint flexion peak torque | MCP joint flexion peak torque is evaluated by the exoskeleton torque joint sensor during the robot-in-charge mobilization sequences | during robot-in-charge mobilization sequences | 
| Numeric Pain Rating Scale (NPRS) | NPRS is an 11-point scale for patient self-reporting of pain, with 0 being no pain and 10 being the worst pain imaginable | 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 | The physiotherapist is required to report any adverse events occurring during the study in regard to the use of WRL HX MCP | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humans, Adult, Diseases, musculoskeletal, Metacarpophalangeal Joints, Range of Motion, Articular, Feasibility Studies, Rehabilitation Research, Robotics, Exoskeleton Device, Wearable Electronic Devices