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

Hand Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155670
• Other study ID #: Habilis 2020
• Status: Completed
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: March 25, 2023

Study information

• Verified date: March 2024
• Source: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 25, 2023
• Est. primary completion date: September 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Injuries

Intervention

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.

Locations

Country	Name	City	State
Italy	INAIL - Centro di Riabilitazione Motoria di Volterra	Volterra	Pisa

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro	Scuola Superiore Sant'Anna di Pisa

Country where clinical trial is conducted

Italy, 

References & Publications (11)

A. Chiri et al.,

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Krebs HI, Volpe BT. Rehabilitation robotics. Handb Clin Neurol. 2013;110:283-94. doi: 10.1016/B978-0-444-52901-5.00023-X. — View Citation

M. Cempini, M. Cortese and N. Vitiello,

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility indicator: completion of study procedures	Percent of participants for whom study procedures were completed successfully	through study completion, an average of 1 year
Primary	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.
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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