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

NCT ID: NCT02657070

Last Updated: 2016-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental Group

Virtual reality based therapy with augmented visuomotor feedback.

Group Type EXPERIMENTAL

Reinforcement-Induced Movement Therapy (RIMT)

Intervention Type BEHAVIORAL

6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) with augmented visuomotor feedback

Control Group

Virtual reality based therapy without augmentation.

Group Type ACTIVE_COMPARATOR

VR-based motor rehabilitation in RGS without augmented feedback

Intervention Type BEHAVIORAL

6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS)

Interventions

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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

Intervention Type 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)

Intervention Type BEHAVIORAL

Other Intervention Names

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VR-based motor rehabilitation in RGS with amplified visuomotor feedback

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Joan XXIII de Tarragona.

OTHER

Sponsor Role collaborator

Universitat Pompeu Fabra

OTHER

Sponsor Role lead

Responsible Party

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Paul Verschure

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosa Maria San Segundo Mozo, Dra.

Role: PRINCIPAL_INVESTIGATOR

Medico Especialista en Medician Fisica y Rehabilitation, Doctora por al Universitat Rovira i Virgili de Tarragona

Paul F.M.J. Verschure, Prof.

Role: STUDY_DIRECTOR

Director SPECS

References

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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.

Reference Type BACKGROUND
PMID: 10714655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7886714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16480566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26684921 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27506203 (View on PubMed)

Other Identifiers

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CEIC 53/2013

Identifier Type: -

Identifier Source: org_study_id

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