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OpenTrials
Completed

NCT Number: NCT02699398

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.

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Key information

Conditions

Hemiparesis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Functional Independence Movement Disorder Movement Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Domiciliary VR-based motor rehabilitation

Behavioral

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

Domiciliary occupational therapy for motor rehabilitation

Behavioral

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

Primary outcomes

  1. 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 outcomes

  1. Change in depression as measured by the Hamilton scale

    Time frame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Universitat Pompeu Fabra

Other

Collaborators

  • Hospital Vall d'Hebron
  • Hospital del Mar

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2016
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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