Domiciliary VR Rehabilitation

February 29, 2016 updated by: Paul Verschure, Universitat Pompeu Fabra
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
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
Time Frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
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
Time Frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
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
Time Frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
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
Time Frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in Grip Force as measured by a grip dynamometer
Time Frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
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
Time Frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
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
Time Frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • AAL-2008-1-1191

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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