Motor Learning of Stroke Patients in Virtual Environments

NCT ID: NCT03583827

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-10
• Study Completion Date: 2020-02-01

Brief Summary

The aim of this study is to assess the motor learning of patients with chronic stroke in virtual environments. Half the patients will undergo conventional therapy and half virtual reality training using virtual game. The study will also include healthy individuals matched for age, sex, schooling and hand laterality.

Detailed Description

Stroke is the main cause of long-term disability in adults and motor learning is vital for recovering from motor sequelae. A number of approaches have been proposed to promote motor learning, including virtual reality, which simulates a real world environment and is based on the assumption that skills acquired in a virtual world will be transferred to the real world. Virtual reality induces use-dependent plastic changes in response to stimulation of higher motor areas, recruiting the memory system containing stored motor programs. As such, these interactive interventions of virtual reality are based on the idea that stimulating the action processing system activates the cortical areas involved in movement execution.

These game characteristics allow activation of the mirror neuron system during the execution or observation of actions. Recent evidence suggests an important role for this neuron system in the improvement or motor recovery of patients. In this respect, observing an action in association with physical training may enhance the effects of motor training on the recovery of patients with stroke.

Conditions

Stroke; Stroke Sequelae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Experimental group patients will be submitted to conventional therapy for 30 minutes and training of the affected upper limb using virtual reality, which will last 20 minutes over twelve sessions (4 weeks).

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

Virtual reality is a simulation of the real world generated by computer software and experienced by users via a man-machine interface, providing them with intensive repetition of complex tasks, directed by visual and auditory stimuli, creating dynamic individual-task interaction, a motivating environment and immediate feedback on performance and results, stimulating motor skill learning and motor control of complex behaviors.

Conventional physical therapy

Intervention Type: OTHER

Exercises of stretching and strengthening of the upper and lower limbs, as well as coordination, gait and balance.

Control Group

The control group will undergo 30 minutes of Conventional physical therapy in twelve sessions (4 weeks).

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type: OTHER

Exercises of stretching and strengthening of the upper and lower limbs, as well as coordination, gait and balance.

Interventions

Virtual reality

Virtual reality is a simulation of the real world generated by computer software and experienced by users via a man-machine interface, providing them with intensive repetition of complex tasks, directed by visual and auditory stimuli, creating dynamic individual-task interaction, a motivating environment and immediate feedback on performance and results, stimulating motor skill learning and motor control of complex behaviors.

Intervention Type: OTHER

Conventional physical therapy

Exercises of stretching and strengthening of the upper and lower limbs, as well as coordination, gait and balance.

Intervention Type: OTHER

Other Intervention Names

Virtual game; Traditional physical therapy

Eligibility Criteria

Inclusion Criteria

• Subjects diagnosed with the first episode of stroke, confirmed by medical imaging examination, unilateral brain injury, lesion time of at least 6 months;
• Right-handed and able to complete the assessment instruments;
• Individuals with affected upper limb movement skills, such as drinking water from a glass;
• Subjects able to remain in the orthostatic position, with or without gait assistive device.

Exclusion Criteria

• Unilateral neglect and uncorrected primary auditory or visual impairment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Tania Campos

Associate Professor and Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tania F Campos, PhD

Role: STUDY_DIRECTOR

Universidade Federal do Rio Grande do Norte

Locations

Department of Physical Therapy-Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Aline GS Fernandes, PhD

Role: CONTACT

linebraga_fisio@yahoo.com.br

+55 84 999862403

Lorenna DM Borges, MS

Role: CONTACT

lorennamacedo@gmail.com

+55 84 987234630

Facility Contacts

Jacilda O Passos, MS

Role: primary

jacilda_band@hotmail.com

+55 84 987121765

Lorenna DM Borges, MS

Role: backup

lorennamacedo@gmail.com

+55 84 987234630

Other Identifiers

475182/2012-0

Identifier Type: -

Identifier Source: org_study_id