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Motor Learning of Stroke Patients in Virtual Environments

Primary Purpose

Stroke, Stroke Sequelae

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Virtual reality
Conventional physical therapy
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Cerebrovascular disorders, Upper extremity, Paresis, Electroencephalography, Psychomotor Performance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Physical Therapy-Federal University of Rio Grande do NorteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change the EEG power of alpha and beta waves
EEG power of alpha and beta waves (uV2) measured before and after the intervention.
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).

Full Information

First Posted
June 7, 2018
Last Updated
November 30, 2019
Sponsor
Universidade Federal do Rio Grande do Norte
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT03583827
Brief Title
Motor Learning of Stroke Patients in Virtual Environments
Official Title
Motor Learning of Stroke Patients in Virtual Environments: Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2014 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Sequelae
Keywords
Cerebrovascular disorders, Upper extremity, Paresis, Electroencephalography, Psychomotor Performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will undergo 30 minutes of Conventional physical therapy in twelve sessions (4 weeks).
Intervention Type
Other
Intervention Name(s)
Virtual reality
Other Intervention Name(s)
Virtual game
Intervention Description
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
Intervention Name(s)
Conventional physical therapy
Other Intervention Name(s)
Traditional physical therapy
Intervention Description
Exercises of stretching and strengthening of the upper and lower limbs, as well as coordination, gait and balance.
Primary Outcome Measure Information:
Title
Change the angle of movement
Description
Angle of extension of the elbow joint (in degrees) measured before and after the intervention.
Time Frame
Change from baseline until 30 days.
Secondary Outcome Measure Information:
Title
Change the EEG power of alpha and beta waves
Description
EEG power of alpha and beta waves (uV2) measured before and after the intervention.
Time Frame
Change from baseline until 30 days.
Title
Change the Absolute error
Description
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).
Time Frame
Change from 15 trials during 20 minutes over twelve sessions (4 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aline GS Fernandes, PhD
Phone
+55 84 999862403
Email
linebraga_fisio@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenna DM Borges, MS
Phone
+55 84 987234630
Email
lorennamacedo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania F Campos, PhD
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physical Therapy-Federal University of Rio Grande do Norte
City
Natal
State/Province
RN
ZIP/Postal Code
59078-970
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacilda O Passos, MS
Phone
+55 84 987121765
Email
jacilda_band@hotmail.com
First Name & Middle Initial & Last Name & Degree
Lorenna DM Borges, MS
Phone
+55 84 987234630
Email
lorennamacedo@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Motor Learning of Stroke Patients in Virtual Environments

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