Counteracting Learned Non-use Through Augmented Visuomotor Feedback in Virtual Reality (RGS)

Not Applicable

Completed

• Conditions: Hemiparesis
• Interventions: Behavioral: Reinforcement-Induced Movement Therapy (RIMT); Behavioral: VR-based motor rehabilitation in RGS without augmented feedback

• Registration Number: NCT02657070
• Lead Sponsor: Universitat Pompeu Fabra

Brief Summary

The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a novel rehabilitation method that augments visuomotor feedback of movements of the patient in virtual reality, is effective in treating hemiparesis resp. learned non-use.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-01
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-14
• Last Update Submitted: 2016-01-14
• Study First Posted: 2016-01-15
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Mild-to-moderate upper-limbs hemiparesis (Proximal Medical Research Council Scale > 2) due to ischemic or hemorrhagic stroke
• Spasticity in the affected limb (Modified Ashworth Scale <3)
• First-ever ischemic or hemorrhagic stroke (>4 weeks post-stroke)
• Sufficient cognitive capacity for following the instruction of the intervention (Mini-Mental State Evaluation >24)

Exclusion Criteria

• Cognitive impairment that impede the correct execution or understanding of the intervention
• Severe impairments in vision or visual perception abilities (such as vision loss or spatial neglect), in spasticity, in communication abilities (such as aphasia or apraxia), severe pain as well as other neuromuscular or orthopedic changes that impede the correct execution of the intervention training
• Mental dysfunctioning during the acute or subacute phase after the stroke.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Reinforcement-Induced Movement Therapy (RIMT)	Virtual reality based therapy with augmented visuomotor feedback.
Control Group	VR-based motor rehabilitation in RGS without augmented feedback	Virtual reality based therapy without augmentation.

Primary Outcome Measures

Name	Time	Method
The upper extremity Fugl-Meyer Assessment	at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up	change from baseline in motor function

Secondary Outcome Measures

Name	Time	Method
Chedoke Arm Hand Inventory	at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up	change from baseline in functional recovery
Barthel Index	at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up	change from baseline in activities of daily living
Hamilton Scale	at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up	change from baseline in measurement of depression