Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-20

Study Completion Date

2019-03-07

Brief Summary

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Stroke creats dependancy of patients due to various associated impairments. The use of low-cost technologies for neurological rehabilitation may be beneficial for the treatment of these patients.

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Detailed Description

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To determine the effectiveness of a structured protocol using semi-immersive virtual reality with commercial videogames for balance, postural control, functional independence, quality of life and motivation in patients who have suffered an ischemic and / or hemorrhagic stroke in subacute phase and are being treated in a mid-stay hospital.

Patients and methods: Randomized Controlled Trial. Simple blind. Control group will receive conventional therapy (physical therapy and occupational therapy) intervention being based on a task-oriented approach, with five weekly sessions of Physical Therapy and Occupational Therapy with duration of 45 minutes per session.

The experimental group will receive in addition to the above an experimental intervention during 8 weeks providing additional treatment using virtual reality semi-immersive complement is added by means of commercial video games implemented with the Xbox 360º video game console in conjunction with the Kinect device.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly distributed to a control group or experimental group using the QuickCalcs application of GraphPad Software.

The following considerations will be taken into account:

Control group: 8 weeks of conventional rehabilitation based on a task-oriented approach. Consisting of five weekly sessions of physical therapy and of occupational therapy, lasting 45 minutes each.

Experimental group: 8 weeks of conventional rehabilitation provided identically as in the control group, plus virtual reality semi-immersive sessions. VR sessions will be applied following a protocol using commercial video games, three days a week (Monday, Wednesday and Friday) after the conventional rehabilitation sessions.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

All assessments will be made by blind evaluators with respect to the established study groups

Study Groups

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Semi-immersive virtual reality

8 week protocol with semi-immersive virtual reality provided with the XBOX 360º video game console and its Kinect device. The commercial video games used will be: Kinect Sports I ®, Kinect Sport II ®, Kinect Joy Ride ® and Kinect Adventures ®.

Group Type EXPERIMENTAL

Semi-immersive virtual reality

Intervention Type OTHER

Each participant will receive 24 additional sessions of semiinmersive virtual Reality therapy sessions on Monday, Wednesday and Friday, after realizing the conventional therapy sessions. The duration of each VR session will be gradually increased in time-intensity (5 minutes during the first week to 20 minutes during the last week) and motor requirements.

Conventional Rehabilitation

Physical therapy and Occupational Therapy based on a task-oriented approach

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type OTHER

Conventional rehabilitation consisting of five weekly sessions of Physical therapy and Occupational Therapy, based on a task-oriented approach, lasting 45 minutes each.

Interventions

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Semi-immersive virtual reality

Each participant will receive 24 additional sessions of semiinmersive virtual Reality therapy sessions on Monday, Wednesday and Friday, after realizing the conventional therapy sessions. The duration of each VR session will be gradually increased in time-intensity (5 minutes during the first week to 20 minutes during the last week) and motor requirements.

Intervention Type OTHER

Conventional Rehabilitation

Conventional rehabilitation consisting of five weekly sessions of Physical therapy and Occupational Therapy, based on a task-oriented approach, lasting 45 minutes each.

Intervention Type OTHER

Other Intervention Names

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Commercial video games Physical therapy and Occupational Therapy

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with CVA in subacute ischemic or hemorrhagic type.
* NIHSS scale score less than 20.
* MoCA test with scores equal to or greater than 14 (mild cognitive impairment or absence of cognitive impairment).
* Modified Rankin scale between 0-4.
* Patients with the ability to maintain autonomous sitting and standing with or without aids.
* Patients who have received the information document of the study and signed the informed consent form.

Exclusion Criteria

* NIHSS scale scores greater than 21 .
* MoCA test with score lower than 14.
* Modified Rankin scale between 5-6.
* Patients without the ability to maintain autonomous sitting.
* Patients who refused to sign the informed consent form.
* Hospital discharge expected at the beginning of the study.
* Patients who at any time have shown worsening of the general state, disinterest or desire to leave the study.

* Pathologies susceptible to worsening or contraindication with virtual reality devices and commercial video games:

* Photosensitive epilepsy.
* Modified Ashworth scale greater than 2.
* Moderate-severe cognitive impairment.
* Visual alterations.
* Non-collaborating patient.
* Behavioral alterations.
* Refusal to treatment with VR systems.
* Presence of other neurological pathologies.
* Other cardiovascular diseases that contraindicate physical exercise.
* Visual or auditory, musculoskeletal, bone or joint alterations in acute or chronic phase that could influence the primary pathology.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No