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

Hemiparesis Clinical Trial

Official title:

Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657070
• Other study ID #: CEIC 53/2013
• Status: Completed
• Phase: N/A
• First received: January 13, 2016
• Last updated: January 14, 2016
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Universitat Pompeu Fabra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis

Intervention

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
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Pompeu Fabra	Hospital Universitari Joan XXIII de Tarragona.

References & Publications (4)

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. — View Citation

Ramachandran VS, Rogers-Ramachandran D. Phantom limbs and neural plasticity. Arch Neurol. 2000 Mar;57(3):317-20. — View 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. — View Citation

Thomas SA, Lincoln NB. Factors relating to depression after stroke. Br J Clin Psychol. 2006 Mar;45(Pt 1):49-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Chedoke Arm Hand Inventory	change from baseline in functional recovery	at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up	No
Secondary	Barthel Index	change from baseline in activities of daily living	at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up	No
Secondary	Hamilton Scale	change from baseline in measurement of depression	at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up	No