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Robot-based Rehabilitation of Upper Limb Impairment in Multiple Sclerosis (MS-ROBOT)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physioassistant: Haptic training
Physioassistant: Sensorimotor training
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Rehabilitation, Robot-assisted therapy

Eligibility Criteria

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

Inclusion:

  • definite Multiple sclerosis, stable phase of the disease
  • no relapses or worsening >1 in the Expanded Disability Status Scale in the last three months,
  • Expanded Disability Status Scale<7.5,
  • Ashworth score at the upper limb lower than 2,
  • Nine-Hole Peg Test between 30 s and 180 s

Exclusion:

  • previous treatment with robot therapy,
  • presence of severe nystagmus,
  • visual acuity less than 4/10
  • major orthopaedic or other disorders interfering with the protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Sensorimotor training

    Haptic training

    Arm Description

    Patients in this arm were assigned to the 'Physioassistant: Haptic training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation. All participating centers used the exact same apparatus and experimental set-up.

    Patients in this arm were assigned to the 'Physioassistant: Sensorimotor training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation. All participating centers used the exact same apparatus and experimental set-up.

    Outcomes

    Primary Outcome Measures

    Change of the 9 Hole Peg Test score

    Secondary Outcome Measures

    Treatment change in percentage of responders at 9 Hole Peg Test score
    Number of responders i.e. the subjects who experienced an improvement greater than 20% at the 9HPT
    Absolute change of exercise performance
    Performance score (a combination of a movement duration and a path length component, with equal weights)
    Absolute change of task difficulty
    Resistive and mass-spring stiffness (Haptic group only)

    Full Information

    First Posted
    February 29, 2016
    Last Updated
    March 11, 2016
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    Collaborators
    University of Genova, Azienda Sanitaria Locale 3 Genovese
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02711566
    Brief Title
    Robot-based Rehabilitation of Upper Limb Impairment in Multiple Sclerosis
    Acronym
    MS-ROBOT
    Official Title
    Robot-based Assessment and Therapy in the Treatment of Upper Limb Impairment in Multiple Sclerosis: a Multi-center, Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    Collaborators
    University of Genova, Azienda Sanitaria Locale 3 Genovese

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke survivors. Robots can be programmed to interact with patients by guiding their movements, by monitoring their performance and by quantifying the type and degree of their impairment. A distinctive element of multiple sclerosis is the involvement of a variety of functional systems, in a way that is highly subject-specific. This requires a personalization of treatment, and continuous adaptation to changes in condition. This points to a need for integrating patient assessment, definition of rehabilitation protocols, their administration and the assessment of their outcome. The goal of this study is to assess, in persons with MS, the efficacy of a type of robot-assisted training that was specifically designed to counteract incoordination and muscle weakness (typical of MS), tailored to individual type and degree of impairment, when compared to simple movement training.
    Detailed Description
    In recent years, the potential of robots in the treatment of persons with motor disabilities has raised considerable interest. These devices may interact with patients by assisting or perturbing their movements, may monitor their performance and even quantify their impairment. Clinical trials involving stroke survivors clearly demonstrated that robot-therapy results in improved motor control. More recently, robot-therapy has been applied to other pathologies. A pilot study carried out by the proponents suggested that Multiple Sclerosis (MS) subjects with predominantly cerebellar symptoms may indeed benefit from robot-therapy. MS subjects with different symptoms may benefit from robot therapy as well, but the variety of symptoms and degrees of impairment that is typical of MS suggests that robots may fully show their potential if therapy is tailored on the individual subjects. In this study, the proponents aim at extending the results of the above mentioned pilot study to MS subjects with a wider variety of impairments. Based on previous studies on robot therapy with MS subjects and stroke survivors, the proponents will develop and test a robot training exercise that is specifically designed to deal with incoordination and/or muscle weakness. In a randomised controlled trial, the proponents will then assess the possible contribution of this form of robot-therapy to the rehabilitation of MS subjects. A population of clinically definite MS subjects with different degrees of upper limb impairment was randomised into 2 groups: (i) Haptic training and (ii) Sensorimotor training. Haptic training was based on a robot-assisted exercise protocol specifically designed to treat cerebellar and motor symptoms in persons with MS by counteracting, respectively, incoordination and muscle weakness. The exercise is based on a motor task - interaction with a virtual mass-spring system under the effect of a resistive load - that requires sophisticated coordination skills. Task difficulty (the time constant of the mass-spring system) and the magnitude of the resistive load (stiffness magnitude of the resistive spring) were automatically adjusted to the individual subjects' upper limb impairment. In Sensorimotor training, the task is exactly the same, but the robot generates no forces. Hand and target position are displayed on the computer screen. This group allowed quantifying the specific contribution of robot assistance to sensorimotor recovery (if any). Both groups performed 8-10 therapy sessions (1 hour/each, 2-3 times per week). Treatment outcome was assessed in terms of the Nine-Hole Peg Test (9HPT) and the ARAT scores.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Rehabilitation, Robot-assisted therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sensorimotor training
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm were assigned to the 'Physioassistant: Haptic training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation. All participating centers used the exact same apparatus and experimental set-up.
    Arm Title
    Haptic training
    Arm Type
    Experimental
    Arm Description
    Patients in this arm were assigned to the 'Physioassistant: Sensorimotor training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation. All participating centers used the exact same apparatus and experimental set-up.
    Intervention Type
    Device
    Intervention Name(s)
    Physioassistant: Haptic training
    Intervention Description
    Subjects in the Haptic training arm had to perform fast-and-accurate reaching movements in different directions. reaching was mediated by a virtual 'tool', consisting of a virtual point mass (m=5 kg) connected to the subjects' hand through a linear spring (stiffness range: Km=200-500 N/m). An additional spring (stiffness range: Kr = 20-70 N/m) was connected between hand a starting point to resist movements. Subjects were instructed to move the virtual point mass as fast as possible through suitable hand motions, so that the mass ends up and stops on the 'target' area.
    Intervention Type
    Device
    Intervention Name(s)
    Physioassistant: Sensorimotor training
    Intervention Description
    Subjects in the Sensorimotor training arm had to perform fast-and-accurate reaching movements in different directions. The manipulandum was only used to record hand movements, but throughout the movement it generated no forces.
    Primary Outcome Measure Information:
    Title
    Change of the 9 Hole Peg Test score
    Time Frame
    baseline and 4 weeks and baseline and 16 weeks
    Secondary Outcome Measure Information:
    Title
    Treatment change in percentage of responders at 9 Hole Peg Test score
    Description
    Number of responders i.e. the subjects who experienced an improvement greater than 20% at the 9HPT
    Time Frame
    baseline and 4 weeks and baseline and 16 weeks
    Title
    Absolute change of exercise performance
    Description
    Performance score (a combination of a movement duration and a path length component, with equal weights)
    Time Frame
    baseline and 4 weeks and baseline and 16 weeks
    Title
    Absolute change of task difficulty
    Description
    Resistive and mass-spring stiffness (Haptic group only)
    Time Frame
    baseline and 4 weeks and baseline and 16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion: definite Multiple sclerosis, stable phase of the disease no relapses or worsening >1 in the Expanded Disability Status Scale in the last three months, Expanded Disability Status Scale<7.5, Ashworth score at the upper limb lower than 2, Nine-Hole Peg Test between 30 s and 180 s Exclusion: previous treatment with robot therapy, presence of severe nystagmus, visual acuity less than 4/10 major orthopaedic or other disorders interfering with the protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claudio M Solaro, MD
    Organizational Affiliation
    ASL 3 Genovese
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    22275705
    Citation
    Basteris A, De Luca A, Sanguineti V, Solaro C, Mueller M, Carpinella I, Cattaneo D, Bertoni R, Ferrarin M. A tailored exercise of manipulation of virtual tools to treat upper limb impairment in Multiple Sclerosis. IEEE Int Conf Rehabil Robot. 2011;2011:5975509. doi: 10.1109/ICORR.2011.5975509.
    Results Reference
    background
    PubMed Identifier
    32145522
    Citation
    Solaro C, Cattaneo D, Basteris A, Carpinella I, De Luca A, Mueller M, Bertoni R, Ferrarin M, Sanguineti V. Haptic vs sensorimotor training in the treatment of upper limb dysfunction in multiple sclerosis: A multi-center, randomised controlled trial. J Neurol Sci. 2020 May 15;412:116743. doi: 10.1016/j.jns.2020.116743. Epub 2020 Feb 19.
    Results Reference
    derived

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    Robot-based Rehabilitation of Upper Limb Impairment in Multiple Sclerosis

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