Clinical trial NCT05155670: Hand Motor Rehabilitation Using a Wearable Robotic Device (WRL HX MCP)
Official title: Hand Motor Rehabilitation Using a Wearable Robotic Device (WRL HX MCP): a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries
Keywords: Humans
Adult
Diseases, musculoskeletal
Metacarpophalangeal Joints
Range of Motion, Articular
Feasibility Studies
Rehabilitation Research
Robotics
Exoskeleton Device
Wearable Electronic Devices
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
Collaborators: name: Scuola Superiore Sant'Anna di Pisa
First posted: 2021-12-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: This study aims to:

1. Test the safety and reliability of the WRL HX MCP device for assisting flexion and extension movement of the stiff metacarpophalangeal joint
2. Conduct a preliminary examination of the efficacy of the device in the treatment of joint stiffness to design a subsequent RCT
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility indicator: completion of study procedures
timeFrame: through study completion, an average of 1 year
measure: Feasibility indicator: patient acceptability
timeFrame: After the robotic therapy session; the total expected time for the session is about 90 minutes.
measure: Feasibility indicator: reliability evaluated through the number of device malfunctions
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Goniometric measure of MCP Active Range of Motion (AROM)
timeFrame: at baseline and immediately after the robotic therapy session.
measure: Goniometric measure of MCP Passive Range of Motion (PROM)
timeFrame: at baseline and immediately after the robotic therapy session
measure: Robotic measure of MCP Active Range of Motion (AROM)
timeFrame: at baseline and immediately after the robotic therapy session
measure: Robotic measure of MCP passive Range of Motion (PROM)
timeFrame: at baseline and immediately after the robotic therapy session
measure: Robotic estimation of MCP joint flexion peak torque
timeFrame: during robot-in-charge mobilization sequences
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: at baseline and after each of the two series of joint mobilization exercises, lasting up to 30 minutes each.
measure: Safety evaluated through the number of adverse events
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Volterra
country: Italy
facility: INAIL - Centro di Riabilitazione Motoria di Volterra
state: Pisa
Study officials:
affiliation: INAIL - Centro di Riabilitazione Motoria di Volterra
name: Elisa Taglione, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The BioRobotics Institute, Scuola Superiore Sant'Anna
name: Simona Crea, PhD
role: STUDY_DIRECTOR
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