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Clinical Trials/NCT02764372
NCT02764372CompletedPhase 1

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

Fondazione Don Carlo Gnocchi Onlus0 sites20 target enrollmentStarted: July 2015Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
20
Primary Endpoint
9 Hole peg test

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

9 Hole peg test

Time Frame: 10 months

Testing pre and post intervention

Box and Block test

Time Frame: 10 months

Testing pre and post intervention

Secondary Outcomes

  • Short Form 12(10 months)
  • the EQ-5D visual analogue scale (EQ-VAS)(10 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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