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Telerehabilitation Upper Extremity for Neurological Disorders (Telerehab)

Primary Purpose

Multiple Sclerosis, Stroke

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Serious games
Exergames
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 Arm rehabilitation, Serious games, stroke, Multiple sclerosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Persons Post stroke or with MS with resultant upper extremity motor deficits.
  • Range of motion of shoulder and elbow equal or higher than 45 degrees.
  • Able to comprehend and follow directions.

Exclusion Criteria:

  • Wearing pace maker
  • Comorbidities affecting arm use
  • Not able to comprehend and follow directions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Serious games

    Exergames

    Arm Description

    The experimental group received Serious Games-based upper extremity therapy through Kinect

    The control played the same amount of time with commercial exergames of the Wii

    Outcomes

    Primary Outcome Measures

    9 Hole peg test
    Testing pre and post intervention
    Box and Block test
    Testing pre and post intervention

    Secondary Outcome Measures

    Short Form 12
    Testing pre and post intervention
    the EQ-5D visual analogue scale (EQ-VAS)
    Testing pre and post intervention

    Full Information

    First Posted
    May 3, 2016
    Last Updated
    May 5, 2016
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    Collaborators
    University of Bremen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02764372
    Brief Title
    Telerehabilitation Upper Extremity for Neurological Disorders
    Acronym
    Telerehab
    Official Title
    Serious Games for Upper Extremity Rehabilitation for Patients With Neurological Disorders: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    Collaborators
    University of Bremen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aims of the present study were to: Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services. Provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with MS. Main results suggest that the serious games approach was positively received in terms of user experience and motivation to use, with the participants showing also improvements in functional abilities of the treated arm.
    Detailed Description
    The objective of this pilot study was to assess the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services. A secondary objective was to provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with multiple sclerosis (MS). A pilot single-blind randomized controlled trial was carried out in an inpatient and ambulatory care at a rehabilitation center. Twenty persons with multiple sclerosis (n=16) or chronic poststroke (n=4) receiving rehabilitation at the center, able to flex shoulder and elbow at least 45 degrees, participated in the study. An intervention group received Serious Games-based upper extremity therapy for a total of 12 sessions (4-5 sessions, lasting 40 minutes, per week) and the control played the same amount of time with commercial exergames of the Wii. Both groups received their usual rehabilitation services as well as game playing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Stroke
    Keywords
    Arm rehabilitation, Serious games, stroke, Multiple sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Serious games
    Arm Type
    Experimental
    Arm Description
    The experimental group received Serious Games-based upper extremity therapy through Kinect
    Arm Title
    Exergames
    Arm Type
    Active Comparator
    Arm Description
    The control played the same amount of time with commercial exergames of the Wii
    Intervention Type
    Behavioral
    Intervention Name(s)
    Serious games
    Other Intervention Name(s)
    virtual reality games
    Intervention Description
    Participants played serious games developed for Kinect in the the EU FP7 STREP Project REHAB@HOME N. 306113
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exergames
    Other Intervention Name(s)
    Wii game console
    Intervention Description
    Participants played exergames existent in the Wii game console
    Primary Outcome Measure Information:
    Title
    9 Hole peg test
    Description
    Testing pre and post intervention
    Time Frame
    10 months
    Title
    Box and Block test
    Description
    Testing pre and post intervention
    Time Frame
    10 months
    Secondary Outcome Measure Information:
    Title
    Short Form 12
    Description
    Testing pre and post intervention
    Time Frame
    10 months
    Title
    the EQ-5D visual analogue scale (EQ-VAS)
    Description
    Testing pre and post intervention
    Time Frame
    10 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Persons Post stroke or with MS with resultant upper extremity motor deficits. Range of motion of shoulder and elbow equal or higher than 45 degrees. Able to comprehend and follow directions. Exclusion Criteria: Wearing pace maker Comorbidities affecting arm use Not able to comprehend and follow directions

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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