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

Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus

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.

Study Overview

• Status: Completed
• Conditions: Hemiparesis
• Intervention / Treatment: Behavioral: Reinforcement-Induced Movement Therapy (RIMT); Behavioral: VR-based motor rehabilitation in RGS without augmented feedback

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Virtual reality based therapy with augmented visuomotor feedback.	Behavioral: Reinforcement-Induced Movement Therapy (RIMT); 6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) with augmented visuomotor feedback; Other Names: VR-based motor rehabilitation in RGS with amplified visuomotor feedback
Active Comparator: Control Group; Virtual reality based therapy without augmentation.	Behavioral: VR-based motor rehabilitation in RGS without augmented feedback; 6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitat Pompeu Fabra
• Collaborators: Hospital Universitari Joan XXIII de Tarragona.
• Investigators: Principal Investigator: Rosa Maria San Segundo Mozo, Dra., Medico Especialista en Medician Fisica y Rehabilitation, Doctora por al Universitat Rovira i Virgili de Tarragona; Study Director: Paul F.M.J. Verschure, Prof., Director SPECS

Publications and helpful links

General Publications

• Robinson RG, Jorge RE. Post-Stroke Depression: A Review. Am J Psychiatry. 2016 Mar 1;173(3):221-31. doi: 10.1176/appi.ajp.2015.15030363. Epub 2015 Dec 18.
• Ramachandran VS, Rogers-Ramachandran D. Phantom limbs and neural plasticity. Arch Neurol. 2000 Mar;57(3):317-20. doi: 10.1001/archneur.57.3.317.
• de Haan RJ, Limburg M, Van der Meulen JH, Jacobs HM, Aaronson NK. Quality of life after stroke. Impact of stroke type and lesion location. Stroke. 1995 Mar;26(3):402-8. doi: 10.1161/01.str.26.3.402.
• Thomas SA, Lincoln NB. Factors relating to depression after stroke. Br J Clin Psychol. 2006 Mar;45(Pt 1):49-61. doi: 10.1348/014466505X34183.
• Ballester BR, Maier M, San Segundo Mozo RM, Castaneda V, Duff A, M J Verschure PF. Counteracting learned non-use in chronic stroke patients with reinforcement-induced movement therapy. J Neuroeng Rehabil. 2016 Aug 9;13(1):74. doi: 10.1186/s12984-016-0178-x.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Estimate): January 15, 2016
• Last Update Submitted That Met QC Criteria: January 14, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Stroke; Virtual Reality; Hemiparesis; learned non-use
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: CEIC 53/2013