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

Motor Learning of Stroke Patients in Virtual Environments



Sponsors


Source

Universidade Federal do Rio Grande do Norte

Oversight Info

Has Dmc

No


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.

Overall Status

Recruiting

Start Date

2014-02-10

Completion Date

2020-02-01

Primary Completion Date

2019-07-20

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change the angle of movement
Change from baseline until 30 days.

Secondary Outcome

Measure

Time Frame

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).

Enrollment

80

Conditions


Intervention

Intervention Type

Other

Intervention Name


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.

Arm Group Label

Experimental Group

Other Name

Virtual game


Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

Experimental Group

Control Group


Other Name

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.

Gender

All

Minimum Age

18 Years

Maximum Age

70 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Tania F Campos, PhD
Study Director
Universidade Federal do Rio Grande do Norte

Overall Contact

Last Name

Aline GS Fernandes, PhD

Phone

+55 84 999862403

Email



Location

Facility

Status

Contact

Department of Physical Therapy-Federal University of Rio Grande do Norte
Natal RN 59078-970 Brazil
Recruiting
Last Name: Jacilda O Passos, MS
Phone: +55 84 987121765
Email: [email protected]

Location Countries

Country

Brazil


Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Universidade Federal do Rio Grande do Norte

Investigator Full Name

Tania Campos

Investigator Title

Associate Professor and Researcher


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Experimental Group

Arm Group Type

Experimental

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 Group Label

Control Group

Arm Group Type

Active Comparator

Description

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



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Lorenna DM Borges, MS

Phone

+55 84 987234630

Email



Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

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.

Primary Purpose

Treatment

Masking

Single (Outcomes Assessor)


Study First Submitted

June 7, 2018

Study First Submitted Qc

June 28, 2018

Study First Posted

July 11, 2018

Last Update Submitted

June 28, 2018

Last Update Submitted Qc

June 28, 2018

Last Update Posted

July 11, 2018


ClinicalTrials.gov processed this data on July 11, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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