Telerehabilitation Upper Extremity for Neurological Disorders (Telerehab)

May 5, 2016 updated by: Fondazione Don Carlo Gnocchi Onlus

Serious Games for Upper Extremity Rehabilitation for Patients With Neurological Disorders: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
9 Hole peg test
Time Frame: 10 months
Testing pre and post intervention
10 months
Box and Block test
Time Frame: 10 months
Testing pre and post intervention
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form 12
Time Frame: 10 months
Testing pre and post intervention
10 months
the EQ-5D visual analogue scale (EQ-VAS)
Time Frame: 10 months
Testing pre and post intervention
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

University of Bremen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rehab2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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