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Robot-assisted Training of the Upper Limb in Persons With Multiple Sclerosis: an Randomized Controlled Trial

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
I-TRAVLE training
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with Multiple Sclerosis (McDonald criteria), upper limb dysfunction due to muscle weakness (Motricity Index <80), age > 18 years

Exclusion Criteria:

  • MS relapse or glucocorticosteroid treatment in the last month before the start of the study, upper limb paralysis (Motricity Index < 18), other sever limitations, influencing participation (cognitive, visual)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group (persons with MS)

    Experimental group (persons with MS)

    Arm Description

    no training

    Robot-assisted training

    Outcomes

    Primary Outcome Measures

    Motricity index
    Random motor activity
    Fugl-Meyer
    Assessment of recovery of motor function
    Action Research arm test
    Grasp, grip, pinch, gross movement
    Motor Activity log
    perceived activities of daily life
    Jamar handgrip strength
    Handgrip strength

    Secondary Outcome Measures

    Full Information

    First Posted
    October 2, 2014
    Last Updated
    July 2, 2015
    Sponsor
    Hasselt University
    Collaborators
    Revalidatie & MS Centrum Overpelt, Expertise Centre for digital Media, tUL, iMinds, Interreg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02257606
    Brief Title
    Robot-assisted Training of the Upper Limb in Persons With Multiple Sclerosis: an Randomized Controlled Trial
    Official Title
    Robot-assisted Training on the Upper Limb in Persons With MS: an RCT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2011 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    September 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hasselt University
    Collaborators
    Revalidatie & MS Centrum Overpelt, Expertise Centre for digital Media, tUL, iMinds, Interreg

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    With this randomised intervention study, the investigators want to investigate the training effect of an 8 week training regime, using a robot-assisted training system in persons with MS. Besides conventional therapy, study participants in the experimental group will train 3 times per week during 30 minutes, using the haptic master. Research questions focus on the effects of additional robot assisted training on range of motion, movement quality and clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16 weeks of follow-

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group (persons with MS)
    Arm Type
    No Intervention
    Arm Description
    no training
    Arm Title
    Experimental group (persons with MS)
    Arm Type
    Experimental
    Arm Description
    Robot-assisted training
    Intervention Type
    Other
    Intervention Name(s)
    I-TRAVLE training
    Primary Outcome Measure Information:
    Title
    Motricity index
    Description
    Random motor activity
    Time Frame
    2.5 min (pre-post)
    Title
    Fugl-Meyer
    Description
    Assessment of recovery of motor function
    Time Frame
    30 min (pre-post)
    Title
    Action Research arm test
    Description
    Grasp, grip, pinch, gross movement
    Time Frame
    15-20 min (pre-post)
    Title
    Motor Activity log
    Description
    perceived activities of daily life
    Time Frame
    45 min (pre-post)
    Title
    Jamar handgrip strength
    Description
    Handgrip strength
    Time Frame
    2.5 min (pre-post)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with Multiple Sclerosis (McDonald criteria), upper limb dysfunction due to muscle weakness (Motricity Index <80), age > 18 years Exclusion Criteria: MS relapse or glucocorticosteroid treatment in the last month before the start of the study, upper limb paralysis (Motricity Index < 18), other sever limitations, influencing participation (cognitive, visual)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26202325
    Citation
    Feys P, Coninx K, Kerkhofs L, De Weyer T, Truyens V, Maris A, Lamers I. Robot-supported upper limb training in a virtual learning environment : a pilot randomized controlled trial in persons with MS. J Neuroeng Rehabil. 2015 Jul 23;12:60. doi: 10.1186/s12984-015-0043-3.
    Results Reference
    derived

    Learn more about this trial

    Robot-assisted Training of the Upper Limb in Persons With Multiple Sclerosis: an Randomized Controlled Trial

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