Clinical trial NCT03583827: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Stroke Sequelae
Keywords: Cerebrovascular disorders
Upper extremity
Paresis
Electroencephalography
Psychomotor Performance
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2018-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: Change the angle of movement
timeFrame: Change from baseline until 30 days.
Secondary outcomes:
measure: Change the EEG power of alpha and beta waves
timeFrame: Change from baseline until 30 days.
measure: Change the Absolute error
timeFrame: Change from 15 trials during 20 minutes over twelve sessions (4 weeks).
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Department of Physical Therapy-Federal University of Rio Grande do Norte
state: RN
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Tania F Campos, PhD
role: STUDY_DIRECTOR
References: