Motor Learning of Stroke Patients in Virtual Environments

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03583827
• Other study ID #: 475182/2012-0
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2014
• Est. completion date: February 1, 2020

Study information

• Verified date: November 2019
• Source: Universidade Federal do Rio Grande do Norte
• Contact: Aline GS Fernandes, PhD
• Phone: +55 84 999862403
• Email: linebraga_fisio[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 1, 2020
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke Sequelae

Intervention

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

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy-Federal University of Rio Grande do Norte	Natal	RN

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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).