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Domiciliary VR Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02699398
Enrollment
39
Registered
2016-03-04
Start date
2011-11-30
Completion date
2013-07-31
Last updated
2016-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Independence, Hemiparesis, Movement Disorder, Stroke

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.

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.

Sponsors

Hospital del Mar
CollaboratorOTHER
Hospital Vall d'Hebron
CollaboratorOTHER
Universitat Pompeu Fabra
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
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

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

Design outcomes

Primary

MeasureTime frame
Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinicalAt baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

Secondary

MeasureTime frame
Change in motor function as measured by the Medical Research Council scaleAt baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in spasticity for the upper arms as measured by the Ashworth scaleAt baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in cognitive function as measured by the Mini-mental State Evaluation testAt baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in depression as measured by the Hamilton scaleAt baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in shoulder pain as measured by the Visual Analog Assessment scaleAt baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in motor function as measured by the upper extremity Fugl-Meyer AssessmentAt baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Change in Grip Force as measured by a grip dynamometerAt baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026