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Telerehabilitation Upper Extremity for Neurological Disorders

Sponsor
Fondazione Don Carlo Gnocchi Onlus (Other)
Overall Status
Completed
CT.gov ID
NCT02764372
Collaborator
University of Bremen (Other)
20
Enrollment
2
Arms
9
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Serious games
  • Behavioral: Exergames
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Serious Games for Upper Extremity Rehabilitation for Patients With Neurological Disorders: A Pilot Study
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Serious games

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

Behavioral: Serious games
Participants played serious games developed for Kinect in the the EU FP7 STREP Project REHAB@HOME N. 306113
Other Names:
  • virtual reality games

    		•
    Active Comparator: Exergames

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

    Behavioral: Exergames
    Participants played exergames existent in the Wii game console
    Other Names:
  • Wii game console

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 9 Hole peg test [10 months]

      Testing pre and post intervention

    2. Box and Block test [10 months]

      Testing pre and post intervention

    Secondary Outcome Measures

    1. Short Form 12 [10 months]

      Testing pre and post intervention

    2. the EQ-5D visual analogue scale (EQ-VAS) [10 months]

      Testing pre and post intervention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fondazione Don Carlo Gnocchi Onlus
    • University of Bremen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Don Carlo Gnocchi Onlus
    ClinicalTrials.gov Identifier:
    NCT02764372
    Other Study ID Numbers:
    • Rehab2016
    First Posted:
    May 6, 2016
    Last Update Posted:
    May 6, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Fondazione Don Carlo Gnocchi Onlus
    Arm rehabilitation
    Serious games
    stroke
    Multiple sclerosis
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Nervous System Diseases
    Sclerosis

    Study Results

    No Results Posted as of May 6, 2016