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CompletedNCT02699398Updated Mar 4, 2016

Domiciliary VR Rehabilitation

An interventional study of Domiciliary VR-based motor rehabilitation and Domiciliary occupational therapy for motor rehabilitation in Hemiparesis, Functional Independence and Movement Disorder, sponsored by Universitat Pompeu Fabra. Completed. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-03-04.

Sponsored by Universitat Pompeu Fabra · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
All
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Study 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.

02

Conditions studied

  • Hemiparesis
  • Functional Independence
  • Movement Disorder
  • Stroke
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In context

Movement Disorders

320 studies on the registry are indexed under Movement Disorders; 98 are open to participants now.

This study's enrollment of 39 is below the median of 46 across 180 interventional studies indexed under Movement Disorders.

Browse Movement Disorders studies →

Lead sponsor

Universitat Pompeu Fabra is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • 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

  • Active comparator
    Control

    3 weeks of home-based occupational therapy for motor training.

    Behavioral: Domiciliary occupational therapy for motor rehabilitation

Interventions

  • BehavioralDomiciliary VR-based motor rehabilitation

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

  • BehavioralDomiciliary occupational therapy for motor rehabilitation

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

06

What researchers measure

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.

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 28784593 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02699398
Lead sponsor
Universitat Pompeu Fabra
Collaborators
Hospital del Mar, Hospital Vall d'Hebron
Responsible party
Paul Verschure (PhD, Universitat Pompeu Fabra) — Principal investigator
First posted
Mar 4, 2016
Start date
Nov 2011
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Mar 4, 2016

Study contacts

Paul Verschure, PhD
principal investigator · Synthetic Perceptive, Emotive and Cognitive Systems group, Department of Information and Communication Technologies at the Universitat Pompeu Fabra (UPF).
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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