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Motor Learning of Stroke Patients in Virtual Environments

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ClinicalTrials.gov Identifier: NCT03583827
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Tania Campos, Universidade Federal do Rio Grande do Norte

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.

Condition or disease Intervention/treatment Phase
Stroke Stroke Sequelae Other: Virtual reality Other: Conventional physical therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Motor Learning of Stroke Patients in Virtual Environments: Randomized Controlled Clinical Trial
Actual Study Start Date : February 10, 2014
Estimated Primary Completion Date : July 20, 2019
Estimated Study Completion Date : February 1, 2020

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 Name: 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 Name: 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 Name: Traditional physical therapy




Primary Outcome Measures :
  1. Change the angle of movement [ Time Frame: Change from baseline until 30 days. ]
    Angle of extension of the elbow joint (in degrees) measured before and after the intervention.


Secondary Outcome Measures :
  1. Change the EEG power of alpha and beta waves [ Time Frame: Change from baseline until 30 days. ]
    EEG power of alpha and beta waves (uV2) measured before and after the intervention.

  2. Change the Absolute error [ Time Frame: Change from 15 trials during 20 minutes over twelve sessions (4 weeks). ]
    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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583827


Contacts
Contact: Aline GS Fernandes, PhD +55 84 999862403 linebraga_fisio@yahoo.com.br
Contact: Lorenna DM Borges, MS +55 84 987234630 lorennamacedo@gmail.com

Locations
Brazil
Department of Physical Therapy-Federal University of Rio Grande do Norte Recruiting
Natal, RN, Brazil, 59078-970
Contact: Jacilda O Passos, MS    +55 84 987121765    jacilda_band@hotmail.com   
Contact: Lorenna DM Borges, MS    +55 84 987234630    lorennamacedo@gmail.com   
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Tania F Campos, PhD Universidade Federal do Rio Grande do Norte

Responsible Party: Tania Campos, Associate Professor and Researcher, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03583827     History of Changes
Other Study ID Numbers: 475182/2012-0
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tania Campos, Universidade Federal do Rio Grande do Norte:
Cerebrovascular disorders
Upper extremity
Paresis
Electroencephalography
Psychomotor Performance

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases