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Trial record 1 of 1 for:    NCT02699398
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Domiciliary VR Rehabilitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02699398
First Posted: March 4, 2016
Last Update Posted: March 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hospital del Mar
Hospital Vall d'Hebron
Information provided by (Responsible Party):
Paul Verschure, Universitat Pompeu Fabra
  Purpose
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 Intervention
Hemiparesis Functional Independence Movement Disorder Stroke Behavioral: Domiciliary VR-based motor rehabilitation Behavioral: Domiciliary occupational therapy for motor rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Paul Verschure, Universitat Pompeu Fabra:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • Change in depression as measured by the Hamilton scale [ Time Frame: 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Enrollment: 39
Study Start Date: November 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699398


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).
  More Information

Responsible Party: Paul Verschure, PhD, Universitat Pompeu Fabra
ClinicalTrials.gov Identifier: NCT02699398     History of Changes
Other Study ID Numbers: AAL-2008-1-1191
First Submitted: February 25, 2016
First Posted: March 4, 2016
Last Update Posted: March 4, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Movement Disorders
Paresis
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms