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Completed

NCT Number: NCT04739644

Robot-based Wrist Rehabilitation in Orthopaedics: Efficacy and Comparison With Traditional Methods

The present randomized clinical trial addresses the issue about the application of robot-based rehabilitation programs in orthopedic conditions. The aim of the study is to test the efficacy of a robot-based rehabilitative protocol to recover wrist functionality after traumatic injuries.

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Key information

Conditions

Wrist Injuries Arm Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Thirty patients with work related wrist injuries resulting in wrist joint dysfunction are enrolled in an open randomized controlled trial over a 24 months period. Each participant is randomly allocated to experimental or control group and receives a 3-week rehabilitation program including both assessment and rehabilitative sessions. While patients in the control group undergo a traditional rehabilitative protocol, the experimental group is treated replacing traditional exercises with robot-aided ones performed with WRISTBOT, a 3 Degrees of Freedom (DoFs) robotic exoskeleton. WRISTBOT allows for passive, active and assisted range-of-motion (ROM) exercises, isotonic and elastic tasks, proprioceptive and perturbation training. All subjects perform the same sessions of assessment, which include two evaluations through the robotic system and clinical measures at the beginning (Tb) and at the end (Te) of the rehabilitative training, and a follow-up through phone call, three months after the end of the treatment (Tf). The assessment sessions include a robot-based evaluation (measurement of ROM, exerted forces, dexterity, and wrist position sense acuity) and clinical measures (Patient Rated Wrist Evaluation, Jebsen-Taylor and Jamar Test). Subjects' level of satisfaction about treatment is asked at the end of the rehabilitative treatment (Te). The primary objective is to evaluate the results of a robot-based rehabilitative approach on wrist functionality after work-related trauma, comparing the effects of robotic therapy with those achieved through a conventional therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Functional and spatial limitations of the wrist joint, following an injury occurred at workplace
  • Post-immobilization phase
  • Temporal distance from the acute event not exceeding 6 months
  • Signed informed consent acquisition

Exclusion criteria

  • Non-compliance with study requirements
  • Pregnancy or breast feeding; Current or prior history of malignancy
  • Open skin at the level of the patient-device interface
  • Sensory deficit at the level of the patient-device interface
  • Acute inflammatory arthritis of the wrist
  • Contraindications to passive movements

Treatment and study plan

Specific wrist rehabilitation by WRISTBOT device

Device

The WRISTBOT is a fully backdrivable manipulandum that allows for movements along its 3 Degrees of Freedom (DoFs) in a human-like Range Of Motion (ROM) of the wrist: 62° flexion/extension (FE), -40°/+45° in ulnar/radial deviation (RUD), and 60° pronation/supination (PS). In addition, the robot permits motions along planes that involve combined multi-DoFs movements. Mechanically, the robot was developed to have low values of inertia, emulating the fluency of natural movements. Each DOF is measured by high resolution incremental encoders and actuated by one brushless motor or two in case of the RUD planes, providing both gravity compensation and continuous torque values necessary to manipulate the human wrist joints. Depending on the torques exerted, the device can be used in either active or assistive/passive modality. The system is integrated with a Virtual Reality environment (VR), useful to provide a visual feedback to the user while he/she is requested to complete the tasks.

Specific wrist rehabilitation performed by the physiotherapist

Other

Passive, active and assisted mobilization

General Rehabilitation

Other

Exercise with elastic bands or weights, exercise of manipulation and dexterity, simulation of daily life activities supervised by the physiotherapist

Primary outcomes

  1. Change from baseline Jamar Test at 3th week

    Time frame: Up to 3 weeks

    Using a hand dynamometer, subjects perform three trials to evaluate the mean static palmar force exerted in kg

  2. Change from baseline Jebsen Taylor Hand Function Test (JTHFT) at 3th week

    Time frame: Up to 3 weeks

    Consist of six items, its aim is to evaluate dexterity in terms of fine motor skills, weighted functional tasks and non-weighted functional tasks. Each item is scored according to the time taken to complete the task

  3. Change from baseline Patient Rated Wrist/Hand Evaluation (PRWE) at 3th week

    Time frame: Up to 3 weeks

    A questionnaire composed of a pain (PRWE-P) and a function (PRWE-F) subscale. Each subsection has a maximum score of 50 and a minimum of 0, where less score points out a better performance

  4. Change from 3th week (Te) Patient Rated Wrist/Hand Evaluation (PRWE) at the follow-up assessment after 3 months (Tf)

    Time frame: Up to 3 months from Te

    A questionnaire composed of a pain (PRWE-P) and a function (PRWE-F) subscale. Each subsection has a maximum score of 50 and a minimum of 0, where less score points out a better performance

  5. Change from baseline Passive ROM (robotic assessment) at 3th week

    Time frame: Up to 3 weeks

    Starting from the neutral position (0° along each DoF), the device moves the wrist of the subject along different directions until subject's maximum tolerance, notified by himself/herself pushing a button with the not injured hand. Target directions are 8 equally distributed in the Flexion-Extension/Radial-Ulnar Deviation (FE/RUD) space, and 2 along Pronation-Supination. Outcome measures consist in the maximum ROM in degrees achieved along each direction.

  6. Change from baseline Active ROM (robotic assessment) at 3th week

    Time frame: Up to 3 weeks

    From the initial neutral position, subjects move actively the device as far as they could, along the same directions of the Passive ROM assessment. Any assistive force is applied, but the weight of the device is compensated during active motions. The outcome measure is the maximum active ROM in degrees achieved along each direction.

  7. Change from baseline Isometric Force (robotic assessment) at 3th week

    Time frame: Up to 3 weeks

    While the device keeps subjects on the wrist neutral position, they are requested to perform a maximal contraction toward different directions. While subjects push towards each target direction, the device resisted to the imposed force, such that no motion is performed. The outcome measure is maximal peak force in Newton measured along each direction (same directions as in ROM assessment).

  8. Change from baseline Target Tracking (robotic assessment) at 3th week

    Time frame: Up to 3 weeks

    Subjects have to follow a target moving on a first order Lissajous trajectory, showed on the screen two-dimensional space. Subjects perform two laps, actively moving in two different directions of rotation (counter and clockwise) across the space described by combinations of FE/RUD motions. The size of the figure is determined by the 75% of the smallest assessed ROM in each direction. The resulting outcome measure is the mean figural error in degrees, i.e. the average angular distance between target and end-effector trajectory in each sampled point.

  9. Change from baseline Joint Position Matching (robotic assessment) at 3th week

    Time frame: Up to 3 weeks

    While the subject is blindfolded, the device moves his/her wrist in a defined direction, until the 75% of the subject's ROM along that direction. After 3 seconds, the wrist is passively brought back to the neutral position. Then, maintaining the blindfolded condition, the subject is asked to reproduce the joint configuration previously assumed passively. Target directions corresponded to the same directions along which the ROM has been assessed. Performance is measured in terms of matching error, i.e. the Euclidean distance between target and matched points. Matching error is measured in degrees.

Secondary outcomes

  1. Number of Recorded Side effects

    Time frame: Through study completion, up to 3 weeks

    Side effects using WRISTBOT device

  2. Patient Satisfaction

    Time frame: After 3 weeks intervention (Te)

    Subjects were asked to indicate their approval rating of the rehabilitation program through a Numerical Rating Scale (NRS) from 0 (least satisfied) to 10 (most satisfied)

Sponsors and collaborators

Lead sponsor

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Other

Collaborators

  • Istituto Italiano di Tecnologia

Registry information

Official study title

Robot-based Wrist Rehabilitation After Orthopaedic Trauma: a Pilot Randomised Controlled Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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