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OpenTrials
Completed

NCT Number: NCT02764372

Telerehabilitation Upper Extremity for Neurological Disorders

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serious games

Behavioral

Participants played serious games developed for Kinect in the the EU FP7 STREP Project REHAB@HOME N. 306113

Other names: virtual reality games

Exergames

Behavioral

Participants played exergames existent in the Wii game console

Other names: Wii game console

Primary outcomes

  1. 9 Hole peg test

    Time frame: 10 months

    Testing pre and post intervention

  2. Box and Block test

    Time frame: 10 months

    Testing pre and post intervention

Secondary outcomes

  1. Short Form 12

    Time frame: 10 months

    Testing pre and post intervention

  2. the EQ-5D visual analogue scale (EQ-VAS)

    Time frame: 10 months

    Testing pre and post intervention

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • University of Bremen

Registry information

Official study title

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

Acronym: Telerehab

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2016
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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