Domiciliary VR Rehabilitation

Not Applicable

Completed

• Conditions: Hemiparesis; Movement Disorder; Stroke; Functional Independence
• Interventions: Behavioral: Domiciliary occupational therapy for motor rehabilitation; Behavioral: Domiciliary VR-based motor rehabilitation

• Registration Number: NCT02699398
• Lead Sponsor: Universitat Pompeu Fabra

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-02
• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-02-29
• Last Update Submitted: 2016-02-29
• Study First Posted: 2016-03-04
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Domiciliary occupational therapy for motor rehabilitation	3 weeks of home-based occupational therapy for motor training.
VR-based therapy	Domiciliary VR-based motor rehabilitation	3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 upper extremity Fugl-Meyer Assessment	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 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 Medical Research Council scale	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.