Domiciliary VR Rehabilitation

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699398
• Other study ID #: AAL-2008-1-1191
• 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

Related Conditions & MeSH terms

• Functional Independence
• Hemiparesis
• Movement Disorder
• Movement Disorders
• Stroke

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