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

Primary Purpose

Wrist Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Specific wrist rehabilitation by WRISTBOT device
Specific wrist rehabilitation performed by the physiotherapist
General rehabilitation
Sponsored by
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Injuries focused on measuring Adult, Humans, Middle aged, Robotics / instrumentation*, Wrist Injuries / physiopathology, Wrist Injuries / rehabilitation*

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental: WRISTBOT Group

    Control group

    Arm Description

    The patients in the "WRISTBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation by WRISTBOT device

    The patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation performed by physiotherapist.

    Outcomes

    Primary Outcome Measures

    Change from baseline Jamar Test at 3th week
    Using a hand dynamometer, subjects perform three trials to evaluate the mean static palmar force exerted in kg
    Change from baseline Jebsen Taylor Hand Function Test (JTHFT) at 3th week
    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
    Change from baseline Patient Rated Wrist/Hand Evaluation (PRWE) at 3th week
    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
    Change from 3th week (Te) Patient Rated Wrist/Hand Evaluation (PRWE) at the follow-up assessment after 3 months (Tf)
    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
    Change from baseline Passive ROM (robotic assessment) at 3th week
    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.
    Change from baseline Active ROM (robotic assessment) at 3th week
    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.
    Change from baseline Isometric Force (robotic assessment) at 3th week
    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).
    Change from baseline Target Tracking (robotic assessment) at 3th week
    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.
    Change from baseline Joint Position Matching (robotic assessment) at 3th week
    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 Outcome Measures

    Number of Recorded Side effects
    Side effects using WRISTBOT device
    Patient Satisfaction
    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)

    Full Information

    First Posted
    January 27, 2021
    Last Updated
    February 1, 2021
    Sponsor
    Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
    Collaborators
    Istituto Italiano di Tecnologia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04739644
    Brief Title
    Robot-based Wrist Rehabilitation in Orthopaedics: Efficacy and Comparison With Traditional Methods
    Official Title
    Robot-based Wrist Rehabilitation After Orthopaedic Trauma: a Pilot Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 7, 2015 (Actual)
    Primary Completion Date
    June 14, 2018 (Actual)
    Study Completion Date
    June 14, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
    Collaborators
    Istituto Italiano di Tecnologia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wrist Injuries
    Keywords
    Adult, Humans, Middle aged, Robotics / instrumentation*, Wrist Injuries / physiopathology, Wrist Injuries / rehabilitation*

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study considers participants divided in two groups: the control group and the experimental group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: WRISTBOT Group
    Arm Type
    Experimental
    Arm Description
    The patients in the "WRISTBOT Group" underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation by WRISTBOT device
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific wrist rehabilitation performed by physiotherapist.
    Intervention Type
    Device
    Intervention Name(s)
    Specific wrist rehabilitation by WRISTBOT device
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Specific wrist rehabilitation performed by the physiotherapist
    Intervention Description
    Passive, active and assisted mobilization
    Intervention Type
    Other
    Intervention Name(s)
    General rehabilitation
    Intervention Description
    Exercise with elastic bands or weights, exercise of manipulation and dexterity, simulation of daily life activities supervised by the physiotherapist
    Primary Outcome Measure Information:
    Title
    Change from baseline Jamar Test at 3th week
    Description
    Using a hand dynamometer, subjects perform three trials to evaluate the mean static palmar force exerted in kg
    Time Frame
    Up to 3 weeks
    Title
    Change from baseline Jebsen Taylor Hand Function Test (JTHFT) at 3th week
    Description
    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
    Time Frame
    Up to 3 weeks
    Title
    Change from baseline Patient Rated Wrist/Hand Evaluation (PRWE) at 3th week
    Description
    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
    Time Frame
    Up to 3 weeks
    Title
    Change from 3th week (Te) Patient Rated Wrist/Hand Evaluation (PRWE) at the follow-up assessment after 3 months (Tf)
    Description
    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
    Time Frame
    Up to 3 months from Te
    Title
    Change from baseline Passive ROM (robotic assessment) at 3th week
    Description
    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.
    Time Frame
    Up to 3 weeks
    Title
    Change from baseline Active ROM (robotic assessment) at 3th week
    Description
    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.
    Time Frame
    Up to 3 weeks
    Title
    Change from baseline Isometric Force (robotic assessment) at 3th week
    Description
    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).
    Time Frame
    Up to 3 weeks
    Title
    Change from baseline Target Tracking (robotic assessment) at 3th week
    Description
    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.
    Time Frame
    Up to 3 weeks
    Title
    Change from baseline Joint Position Matching (robotic assessment) at 3th week
    Description
    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.
    Time Frame
    Up to 3 weeks
    Secondary Outcome Measure Information:
    Title
    Number of Recorded Side effects
    Description
    Side effects using WRISTBOT device
    Time Frame
    Through study completion, up to 3 weeks
    Title
    Patient Satisfaction
    Description
    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)
    Time Frame
    After 3 weeks intervention (Te)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paolo Catitti, MD
    Organizational Affiliation
    Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Robot-based Wrist Rehabilitation in Orthopaedics: Efficacy and Comparison With Traditional Methods

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