Hand Motor Rehabilitation Using a Wearable Robotic Device (WRL HX MCP)
NCT ID: NCT05155670
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2021-03-26
2023-03-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* hand size allowing to achieve proper exoskeleton fit
* NRS pain score in the 1-5 range
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Scuola Superiore Sant'Anna di Pisa
OTHER
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
OTHER
Responsible Party
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Principal Investigators
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Elisa Taglione, MD
Role: PRINCIPAL_INVESTIGATOR
INAIL - Centro di Riabilitazione Motoria di Volterra
Simona Crea, PhD
Role: STUDY_DIRECTOR
The BioRobotics Institute, Scuola Superiore Sant'Anna
Locations
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INAIL - Centro di Riabilitazione Motoria di Volterra
Volterra, Pisa, Italy
Countries
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References
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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.,
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.
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.
Other Identifiers
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Habilis 2020
Identifier Type: -
Identifier Source: org_study_id
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