Motor Learning of Stroke Patients in Virtual Environments

NCT03583827 | Unknown

• 1 other identifier: 475182/2012-0
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke Sequelae

Keywords

Cerebrovascular disorders; Upper extremity; Paresis; Electroencephalography; Psychomotor Performance

Outcome Measures

Primary Outcomes (1)

• Change the angle of movement

  Angle of extension of the elbow joint (in degrees) measured before and after the intervention.

  Change from baseline until 30 days.

Secondary Outcomes (2)

• Change the EEG power of alpha and beta waves

  Change from baseline until 30 days.

• Change the Absolute error

  Change from 15 trials during 20 minutes over twelve sessions (4 weeks).

Study Arms (2)

Experimental Group

EXPERIMENTAL

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).

Other: Virtual reality; Other: Conventional physical therapy

Control Group

ACTIVE COMPARATOR

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

Other: Conventional physical therapy

Interventions

Virtual reality 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.

Also known as: Virtual game

Experimental Group

Conventional physical therapy OTHER

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

Also known as: Traditional physical therapy

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unilateral neglect and uncorrected primary auditory or visual impairment.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

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

Natal, Rio Grande do Norte, 59078-970, Brazil

RECRUITING

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Paresis

Condition Hierarchy (Ancestors)

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

Study Officials

• Tania F Campos, PhD

  Universidade Federal do Rio Grande do Norte

  STUDY DIRECTOR

Central Study Contacts

Aline GS Fernandes, PhD

CONTACT

+55 84 999862403; linebraga_fisio@yahoo.com.br

Lorenna DM Borges, MS

CONTACT

+55 84 987234630; lorennamacedo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Researcher

Model Details: Eighty unilaterally brain injured right-handed patients, with lesion time of 6 months or more, aged 70 years or younger, 40 with left-brain and 40 with right-brain injury, will take part in the study. They will be randomly divided into a control group (GC), which will undergo conventional therapy and an experimental group (EG), which will be submitted to conventional and virtual reality training using the game virtual. The study will also include 40 healthy individuals matched for age, sex, schooling and hand laterality.

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: July 11, 2018
• Study Start: February 10, 2014
• Primary Completion: November 20, 2019
• Study Completion: February 1, 2020
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)