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

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

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.

Study Overview

• Status: Completed
• Conditions: Hand Injuries
• Intervention / Treatment: Device: WRL HX MCP

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa
    • Volterra, Pisa, Italy, 56048
      • INAIL - Centro di Riabilitazione Motoria di Volterra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Robotic therapy; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
• Collaborators: Scuola Superiore Sant'Anna di Pisa
• Investigators: Principal Investigator: Elisa Taglione, MD, INAIL - Centro di Riabilitazione Motoria di Volterra; Study Director: Simona Crea, PhD, The BioRobotics Institute, Scuola Superiore Sant'Anna

Publications and helpful links

General Publications

• Cempini M, Marzegan A, Rabuffetti M, Cortese M, Vitiello N, Ferrarin M. Analysis of relative displacement between the HX wearable robotic exoskeleton and the user's hand. J Neuroeng Rehabil. 2014 Oct 18;11:147. doi: 10.1186/1743-0003-11-147.
• Kollitz KM, Hammert WC, Vedder NB, Huang JI. Metacarpal fractures: treatment and complications. Hand (N Y). 2014 Mar;9(1):16-23. doi: 10.1007/s11552-013-9562-1.
• Evans RB. Managing the injured tendon: current concepts. J Hand Ther. 2012 Apr-Jun;25(2):173-89; quiz 190. doi: 10.1016/j.jht.2011.10.004. Epub 2012 Feb 11.
• Ye L, Kalichman L, Spittle A, Dobson F, Bennell K. Effects of rehabilitative interventions on pain, function and physical impairments in people with hand osteoarthritis: a systematic review. Arthritis Res Ther. 2011 Feb 18;13(1):R28. doi: 10.1186/ar3254.
• Metcalf C, Adams J, Burridge J, Yule V, Chappell P. A review of clinical upper limb assessments within the framework of the WHO ICF. Musculoskeletal Care. 2007 Sep;5(3):160-73. doi: 10.1002/msc.108.
• Krebs HI, Volpe BT. Rehabilitation robotics. Handb Clin Neurol. 2013;110:283-94. doi: 10.1016/B978-0-444-52901-5.00023-X.
• M. Cempini, M. Cortese and N. Vitiello,
• Soekadar SR, Witkowski M, Gomez C, Opisso E, Medina J, Cortese M, Cempini M, Carrozza MC, Cohen LG, Birbaumer N, Vitiello N. Hybrid EEG/EOG-based brain/neural hand exoskeleton restores fully independent daily living activities after quadriplegia. Sci Robot. 2016 Dec 6;1(1):eaag3296. doi: 10.1126/scirobotics.aag3296. Epub 2016 Nov 16.
• Marconi, D., Baldoni, A., McKinney, Z., Cempini, M., Crea, S., & Vitiello, N. (2019). A novel hand exoskeleton with series elastic actuation for modulated torque transfer. Mechatronics, 61, 69-82. https://doi.org/10.1016/j.mechatronics.2019.06.001
• Carpinella I, Mazzoleni P, Rabuffetti M, Thorsen R, Ferrarin M. Experimental protocol for the kinematic analysis of the hand: definition and repeatability. Gait Posture. 2006 Jun;23(4):445-54. doi: 10.1016/j.gaitpost.2005.05.001. Epub 2005 Jun 22.
• A. Chiri et al.,

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Actual): September 25, 2022
• Study Completion (Actual): March 25, 2023

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Humans; Robotics; Adult; Exoskeleton Device; Feasibility Studies; Range of Motion, Articular; Wearable Electronic Devices; Rehabilitation Research; Diseases, musculoskeletal; Metacarpophalangeal Joints
• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries
• Other Study ID Numbers: Habilis 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No