Telerehabilitation Upper Extremity for Neurological Disorders

NCT ID: NCT02764372

Last Updated: 2016-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Serious games

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

Group Type EXPERIMENTAL

Serious games

Intervention Type BEHAVIORAL

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

Exergames

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

Group Type ACTIVE_COMPARATOR

Exergames

Intervention Type BEHAVIORAL

Participants played exergames existent in the Wii game console

Interventions

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Serious games

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

Intervention Type BEHAVIORAL

Exergames

Participants played exergames existent in the Wii game console

Intervention Type BEHAVIORAL

Other Intervention Names

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virtual reality games Wii game console

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bremen

OTHER

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Rehab2016

Identifier Type: -

Identifier Source: org_study_id

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