Domiciliary VR Rehabilitation

Sponsor

Universitat Pompeu Fabra (Other)

Overall Status

Completed

CT.gov ID

NCT02699398

Collaborator

Hospital del Mar (Other), Hospital Vall d'Hebron (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.

Condition or Disease	Intervention/Treatment	Phase
Hemiparesis Functional Independence Movement Disorder Stroke	Behavioral: Domiciliary VR-based motor rehabilitation Behavioral: Domiciliary occupational therapy for motor rehabilitation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VR-based therapy 3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup.	Behavioral: Domiciliary VR-based motor rehabilitation 3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
Active Comparator: Control 3 weeks of home-based occupational therapy for motor training.	Behavioral: Domiciliary occupational therapy for motor rehabilitation 3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.

Arm

Intervention/Treatment

Experimental: VR-based therapy

3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup.

Behavioral: Domiciliary VR-based motor rehabilitation

3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.

Active Comparator: Control

3 weeks of home-based occupational therapy for motor training.

Behavioral: Domiciliary occupational therapy for motor rehabilitation

3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.

Outcome Measures

Primary Outcome Measures

Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical [At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.]

Secondary Outcome Measures

Change in depression as measured by the Hamilton scale [At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.]
Change in motor function as measured by the Medical Research Council scale [At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.]
Change in spasticity for the upper arms as measured by the Ashworth scale [At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.]
Change in cognitive function as measured by the Mini-mental State Evaluation test [At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.]
Change in Grip Force as measured by a grip dynamometer [At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.]
Change in shoulder pain as measured by the Visual Analog Assessment scale [At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.]
Change in motor function as measured by the upper extremity Fugl-Meyer Assessment [At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of Hemorrhagic or ischemic stroke
Subject had the stroke more than 12 months ago.
Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale>2) secondary to a first-ever stroke.
Age between 45 and 85 years old.
Subject has previous experience using the RGS system in the clinic.

Exclusion Criteria:

Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universitat Pompeu Fabra
Hospital del Mar
Hospital Vall d'Hebron

Investigators

Principal Investigator: Paul Verschure, PhD, Synthetic Perceptive, Emotive and Cognitive Systems group, Department of Information and Communication Technologies at the Universitat Pompeu Fabra (UPF).

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul Verschure, PhD, Universitat Pompeu Fabra

ClinicalTrials.gov Identifier:

NCT02699398

Other Study ID Numbers:

AAL-2008-1-1191

First Posted:

Mar 4, 2016

Last Update Posted:

Mar 4, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

Movement Disorders

Paresis

Study Results

No Results Posted as of Mar 4, 2016