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OpenTrials
Completed

NCT Number: NCT02657070

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

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.

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Key information

Conditions

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

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: VR-based motor rehabilitation in RGS with amplified visuomotor feedback

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)

Primary outcomes

  1. The upper extremity Fugl-Meyer Assessment

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

    change from baseline in motor function

Secondary outcomes

  1. Chedoke Arm Hand Inventory

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

    change from baseline in functional recovery

  2. Barthel Index

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

    change from baseline in activities of daily living

  3. Hamilton Scale

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

    change from baseline in measurement of depression

Sponsors and collaborators

Lead sponsor

Universitat Pompeu Fabra

Other

Collaborators

  • Hospital Universitari Joan XXIII de Tarragona.

Registry information

Official study title

Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2016
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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