Domiciliary VR Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis; Movement Disorder; Functional Independence
• Intervention / Treatment: Behavioral: Domiciliary VR-based motor rehabilitation; Behavioral: Domiciliary occupational therapy for motor rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Universitat Pompeu Fabra
• Collaborators: 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).

Publications and helpful links

General Publications

• Ballester BR, Nirme J, Camacho I, Duarte E, Rodriguez S, Cuxart A, Duff A, Verschure PFMJ. Domiciliary VR-Based Therapy for Functional Recovery and Cortical Reorganization: Randomized Controlled Trial in Participants at the Chronic Stage Post Stroke. JMIR Serious Games. 2017 Aug 7;5(3):e15. doi: 10.2196/games.6773.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Paresis
• Other Study ID Numbers: AAL-2008-1-1191