Telerehabilitation Upper Extremity for Neurological Disorders

Stroke Clinical Trial

— Telerehab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764372
• Other study ID #: Rehab2016
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2016
• Last updated: May 5, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Nervous System Diseases
• Stroke

Intervention

Behavioral:
• Serious games
Participants played serious games developed for Kinect in the the EU FP7 STREP Project REHAB@HOME N. 306113
• Exergames
Participants played exergames existent in the Wii game console

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	University of Bremen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	9 Hole peg test	Testing pre and post intervention	10 months	No
Primary	Box and Block test	Testing pre and post intervention	10 months	No
Secondary	Short Form 12	Testing pre and post intervention	10 months	No
Secondary	the EQ-5D visual analogue scale (EQ-VAS)	Testing pre and post intervention	10 months	No