Clinical trial NCT02699398: Domiciliary VR Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Functional Independence
Movement Disorder
Stroke
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
Collaborators: name: Hospital del Mar
name: Hospital Vall d'Hebron
First posted: 2016-03-04
Enrollment: 39
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical
timeFrame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Secondary outcomes:
measure: Change in depression as measured by the Hamilton scale
timeFrame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
measure: Change in motor function as measured by the Medical Research Council scale
timeFrame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
measure: Change in spasticity for the upper arms as measured by the Ashworth scale
timeFrame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
measure: Change in cognitive function as measured by the Mini-mental State Evaluation test
timeFrame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
measure: Change in Grip Force as measured by a grip dynamometer
timeFrame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
measure: Change in shoulder pain as measured by the Visual Analog Assessment scale
timeFrame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
measure: Change in motor function as measured by the upper extremity Fugl-Meyer Assessment
timeFrame: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
Other outcomes:
Locations:
Study officials:
affiliation: Synthetic Perceptive, Emotive and Cognitive Systems group, Department of Information and Communication Technologies at the Universitat Pompeu Fabra (UPF).
name: Paul Verschure, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.