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

NCT05155670 | Completed

• 1 other identifier: Habilis 2020
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Injuries

Keywords

Humans; Adult; Diseases, musculoskeletal; Metacarpophalangeal Joints; Range of Motion, Articular; Feasibility Studies; Rehabilitation Research; Robotics; Exoskeleton Device; Wearable Electronic Devices

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (1)

Robotic therapy

EXPERIMENTAL

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

Interventions

WRL HX MCP DEVICE

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.

Robotic therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro: lead
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (1)

INAIL - Centro di Riabilitazione Motoria di Volterra

Volterra, Pisa, 56048, Italy

Location

Related Publications (12)

• 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.

  PMID: 24570632 BACKGROUND

• 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.

  PMID: 22326362 BACKGROUND

• 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.

  PMID: 21332991 BACKGROUND

• 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.

  PMID: 17610309 BACKGROUND

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

  PMID: 23312648 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 33157855 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 15978812 BACKGROUND

• A. Chiri et al.,

  BACKGROUND

• 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.

  PMID: 25326697 BACKGROUND

• Peperoni E, Trigili E, Capotorti E, Capitani SL, Fiumalbi T, Pettinelli F, Grandi S, Rapalli A, Lentini G, Creatini I, Vitiello N, Taglione E, Crea S. Post-traumatic hand rehabilitation using a powered metacarpal-phalangeal exoskeleton: a pilot study. J Neuroeng Rehabil. 2024 Dec 19;21(1):214. doi: 10.1186/s12984-024-01511-w.

  PMID: 39702346 DERIVED

MeSH Terms

Conditions

Hand Injuries; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Elisa Taglione, MD

  INAIL - Centro di Riabilitazione Motoria di Volterra

  PRINCIPAL INVESTIGATOR

• Simona Crea, PhD

  The BioRobotics Institute, Scuola Superiore Sant'Anna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 13, 2021
• Study Start: March 26, 2021
• Primary Completion: September 25, 2022
• Study Completion: March 25, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)