Clinical trial NCT02657070: Counteracting Learned Non-use Through Augmented Visuomotor Feedback in Virtual Reality (RGS)
Official title: Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Keywords: Stroke
learned non-use
Virtual Reality
Hemiparesis
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Joan XXIII de Tarragona.
First posted: 2016-01-15
Enrollment: 23
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The upper extremity Fugl-Meyer Assessment
timeFrame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
Secondary outcomes:
measure: Chedoke Arm Hand Inventory
timeFrame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
measure: Barthel Index
timeFrame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
measure: Hamilton Scale
timeFrame: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Medico Especialista en Medician Fisica y Rehabilitation, Doctora por al Universitat Rovira i Virgili de Tarragona
name: Rosa Maria San Segundo Mozo, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Director SPECS
name: Paul F.M.J. Verschure, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.