Telerehabilitation Upper Extremity for Neurological Disorders

Phase 1

Completed

• Conditions: Stroke; Multiple Sclerosis
• Interventions: Behavioral: Serious games; Behavioral: Exergames

• Registration Number: NCT02764372
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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 Timeline

• Study Start: 2015-07
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-05
• Last Update Submitted: 2016-05-05
• Study First Posted: 2016-05-06
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serious games	Serious games	The experimental group received Serious Games-based upper extremity therapy through Kinect
Exergames	Exergames	The control played the same amount of time with commercial exergames of the Wii

Primary Outcome Measures

Name	Time	Method
9 Hole peg test	10 months	Testing pre and post intervention
Box and Block test	10 months	Testing pre and post intervention

Secondary Outcome Measures

Name	Time	Method
Short Form 12	10 months	Testing pre and post intervention
the EQ-5D visual analogue scale (EQ-VAS)	10 months	Testing pre and post intervention