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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02699398
Other study ID # AAL-2008-1-1191
Secondary ID
Status Completed
Phase N/A
First received February 25, 2016
Last updated February 29, 2016
Start date November 2011
Est. completion date July 2013

Study information

Verified date February 2016
Source Universitat Pompeu Fabra
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 85 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Universitat Pompeu Fabra Hospital del Mar, Hospital Vall d'Hebron

Outcome

Type Measure Description Time frame Safety issue
Primary Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in depression as measured by the Hamilton scale At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in motor function as measured by the Medical Research Council scale At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in spasticity for the upper arms as measured by the Ashworth scale At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in cognitive function as measured by the Mini-mental State Evaluation test At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in Grip Force as measured by a grip dynamometer At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in shoulder pain as measured by the Visual Analog Assessment scale At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in motor function as measured by the upper extremity Fugl-Meyer Assessment At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
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