Clinical trial NCT03528395: Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation
Official title: Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Balance
Baropodometry
Video games
Virtual reality
Lead sponsor: Hospital La Fuenfría
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2018-05-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Timed get up and go
timeFrame: eight weeks
Secondary outcomes:
measure: Tinetti scale
timeFrame: eight weeks
measure: Baropodometry
timeFrame: eight weeks
measure: Static Posturography
timeFrame: eight weeks
measure: Functional reach test
timeFrame: eight weeks
measure: Modified Rankin scale
timeFrame: eight weeks
measure: Barthel index
timeFrame: eight weeks
measure: EQ-5D Questionnaire
timeFrame: eight weeks
measure: Cano-Mañas scale
timeFrame: eight weeks
Other outcomes:
Locations:
city: Cercedilla
country: Spain
facility: Hospital La Fuenfría
state: Madrid
Study officials:
affiliation: Hospital La Fuenfría
name: MªJosé Cano Mañas, PhD program
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Rey Juan Carlos
name: Roberto Cano de la Cuerda, PhD
role: STUDY_DIRECTOR
References:
citation: Cano-Manas MJ, Collado-Vazquez S, Cano-de-la-Cuerda R. [Commercial video games in the rehabilitation of patients with sub-acute stroke: a pilot study]. Rev Neurol. 2017 Oct 16;65(8):337-347. Spanish.
citation: Cano-Manas MJ, Collado-Vazquez S, Rodriguez Hernandez J, Munoz Villena AJ, Cano-de-la-Cuerda R. Effects of Video-Game Based Therapy on Balance, Postural Control, Functionality, and Quality of Life of Patients with Subacute Stroke: A Randomized Controlled Trial. J Healthc Eng. 2020 Feb 13;2020:5480315. doi: 10.1155/2020/5480315. eCollection 2020.