Motor Learning of Stroke Patients in Virtual Environments

Motor Learning of Stroke Patients in Virtual Environments: Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Stroke Sequelae
• Intervention / Treatment: Other: Virtual reality; Other: Conventional physical therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RN
    • Natal, RN, Brazil, 59078-970
      • Recruiting
      • Department of Physical Therapy-Federal University of Rio Grande do Norte
      • Contact: Lorenna DM Borges, MS; Phone Number: +55 84 987234630; Email: lorennamacedo@gmail.com
      • Contact: Jacilda O Passos, MS; Phone Number: +55 84 987121765; Email: jacilda_band@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: 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.; Other Names: Virtual game; Other: Conventional physical therapy; Exercises of stretching and strengthening of the upper and lower limbs, as well as coordination, gait and balance.; Other Names: Traditional physical therapy
Active Comparator: Control Group; The control group will undergo 30 minutes of Conventional physical therapy in twelve sessions (4 weeks).	Other: Conventional physical therapy; Exercises of stretching and strengthening of the upper and lower limbs, as well as coordination, gait and balance.; Other Names: Traditional physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change the EEG power of alpha and beta waves	EEG power of alpha and beta waves (uV2) measured before and after the intervention.	Change from baseline until 30 days.
Change the Absolute error	Absolute error evaluated by score which may vary from 0 (no error, the dart hits the central target) to 5 (maximum error, the dart does not hits the target).	Change from 15 trials during 20 minutes over twelve sessions (4 weeks).

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Study Director: Tania F Campos, PhD, Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2014
• Primary Completion (Actual): November 20, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 30, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Upper extremity; Electroencephalography; Cerebrovascular disorders; Paresis; Psychomotor Performance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 475182/2012-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No