AzTrials
AzTrials

Hand InjuriesNCT05155670

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

A study testing WRL HX MCP in people with Hand Injuries, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hand Injuries
What is being tested?
WRL HX MCP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteItaly
Study dates
26 Mar 2021to 25 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • INAIL - Centro di Riabilitazione Motoria di Volterra

    Volterra, Pisa, 56048

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions
Hand Injuries
Being tested
WRL HX MCP
Keywords
Humans, Adult, Diseases, musculoskeletal, Metacarpophalangeal Joints, Range of Motion, Articular, Feasibility Studies, Rehabilitation Research, Robotics, Exoskeleton Device, Wearable Electronic Devices
Medical subject headings
Hand Injuries, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WRL HX MCPDevice

    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.

Study groups in NCT05155670
Study groupRoleWhat they receive
Robotic therapyExperimentalAll 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.
Receives: Device: WRL HX MCP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility indicator: completion of study procedures

    Percent of participants for whom study procedures were completed successfully

    Measured: through study completion, an average of 1 year

  2. Feasibility indicator: patient acceptability

    Clinician-generated questionnaire to investigate patients' impressions about the physical interaction with the robotic device

    Measured: After the robotic therapy session; the total expected time for the session is about 90 minutes.

  3. 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

    Measured: through study completion, an average of 1 year

Secondary outcomes (7)

  1. 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

    Measured: at baseline and immediately after the robotic therapy session.

  2. 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

    Measured: at baseline and immediately after the robotic therapy session

  3. 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.

    Measured: at baseline and immediately after the robotic therapy session

  4. 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.

    Measured: at baseline and immediately after the robotic therapy session

  5. 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

    Measured: during robot-in-charge mobilization sequences

  6. 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"

    Measured: at baseline and after each of the two series of joint mobilization exercises, lasting up to 30 minutes each.

  7. 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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start26 Mar 2021
  3. Primary completion25 Sep 2022
  4. Study completion25 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155670
Sponsor's protocol ID
Habilis 2020
Status last verified
Mar 2024
First submitted
21 Nov 2021
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24570632

  • 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.

    PubMed 22326362

  • 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.

    PubMed 21332991

  • 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.

    PubMed 17610309

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

    PubMed 23312648

  • 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.

    PubMed 33157855

  • 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.

    PubMed 15978812

  • 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.

    PubMed 25326697

  • 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.

    PubMed 39702346

Questions about this trial

What is this clinical trial studying?

A study testing WRL HX MCP in people with Hand Injuries, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility indicator: completion of study procedures (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05155670, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in