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

NCT02657070 | Completed

• 1 other identifier: CEIC 53/2013
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemiparesis

Keywords

Stroke; learned non-use; Virtual Reality; Hemiparesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Chedoke Arm Hand Inventory

  at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up

• Barthel Index

  at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up

• Hamilton Scale

  at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up

Study Arms (2)

Experimental Group

EXPERIMENTAL

Virtual reality based therapy with augmented visuomotor feedback.

Behavioral: Reinforcement-Induced Movement Therapy (RIMT)

Control Group

ACTIVE COMPARATOR

Virtual reality based therapy without augmentation.

Behavioral: VR-based motor rehabilitation in RGS without augmented feedback

Interventions

Reinforcement-Induced Movement Therapy (RIMT) BEHAVIORAL

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

Also known as: VR-based motor rehabilitation in RGS with amplified visuomotor feedback

Experimental Group

VR-based motor rehabilitation in RGS without augmented feedback BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Pompeu Fabra: lead
• Hospital Universitari Joan XXIII de Tarragona.: collaborator

Related Publications (5)

• 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.

  PMID: 10714655 BACKGROUND

• 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.

  PMID: 7886714 BACKGROUND

• 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.

  PMID: 16480566 BACKGROUND

• 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.

  PMID: 26684921 BACKGROUND

• 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.

  PMID: 27506203 DERIVED

MeSH Terms

Conditions

Paresis; Stroke

Interventions

PITX2 protein, human

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rosa Maria San Segundo Mozo, Dra.

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

  PRINCIPAL INVESTIGATOR

• Paul F.M.J. Verschure, Prof.

  Director SPECS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 15, 2016
• Study Start: March 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 15, 2016

Record last verified: 2016-01