Clinical trial NCT03896542: The Effects of Video Games in Stroke
Official title: The Efficacy of Video Game Therapy in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aims: To establish whether the effectiveness of conventional treatment is increased when it is complemented with video-based therapy, whether specific rehabilitation or commercial after subacute stroke.

Design: Randomized clinical trial with pre / post-test and follow-up evaluation, assessor blinded study.

Methodology: Three different groups: conventional treatment, conventional treatment and commercial videogame, or conventional treatment and specific rehabilitation videogame. The three groups completed 12 sessions.


Eligibility criteria: Inclusion Criteria:

* Patients with stroke
* Hemiplegia on the non-dominant side
* More than 1 month since the stroke
* Score 3 in the shoulder and 2 in the elbow in the modified Medical Research Council scale
* No auditory alterations
* No visual disturbances
* Mini Mental Scale greater than or equal to 24

Exclusion Criteria:

* Patients with unstable blood pressure or angina.
* History of seizures.
* Do not use video games

Primary outcomes:
measure: Strength
timeFrame: Change from baseline at post 12 sessions of intervention and follow-up four weeks after having finished the intervention.
measure: Range of motion
timeFrame: Change from baseline at post 12 sessions of intervention and follow-up four weeks after having finished the intervention.
Secondary outcomes:
measure: Activities of daily living
timeFrame: The measure was administrated in three times: pre intervention, post intervention (after 12 sessions carried out along four weeks) and follow-up four weeks after having finished the intervention.
measure: Fulg Meyer Assessment (FMA)
timeFrame: The measure was administrated in three times: pre intervention, post intervention (after 12 sessions carried out along four weeks) and follow-up four weeks after having finished the intervention.
measure: Box and Blocks test
timeFrame: The measure was administrated in three times: pre intervention, post intervention (after 12 sessions carried out along four weeks) and follow-up four weeks after having finished the intervention.
measure: Muscle tone
timeFrame: The measure was administrated in three times: pre intervention, post intervention (after 12 sessions carried out along four weeks) and follow-up four weeks after having finished the intervention.
Other outcomes:
measure: The ID-Pain© the Lattineen Index.
timeFrame: The measure was administrated in three times: pre intervention, post intervention (after 12 sessions carried out along four weeks) and follow-up four weeks after having finished the intervention.
measure: Lattineen Index.
timeFrame: The measure was administrated in three times: pre intervention, post intervention (after 12 sessions carried out along four weeks) and follow-up four weeks after having finished the intervention.
Locations:
city: Burgos
country: Spain
facility: Universidad de Burgos
Study officials:
affiliation: Universidad de Burgos
name: J. Hilario Ortiz Huerta
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.
citation: Sin H, Lee G. Additional virtual reality training using Xbox Kinect in stroke survivors with hemiplegia. Am J Phys Med Rehabil. 2013 Oct;92(10):871-80. doi: 10.1097/PHM.0b013e3182a38e40.
citation: Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3.
citation: Rand D, Weingarden H, Weiss R, Yacoby A, Reif S, Malka R, Shiller DA, Zeilig G. Self-training to improve UE function at the chronic stage post-stroke: a pilot randomized controlled trial. Disabil Rehabil. 2017 Jul;39(15):1541-1548. doi: 10.1080/09638288.2016.1239766. Epub 2016 Oct 28.
citation: Gauthier LV, Kane C, Borstad A, Strahl N, Uswatte G, Taub E, Morris D, Hall A, Arakelian M, Mark V. Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis. BMC Neurol. 2017 Jun 8;17(1):109. doi: 10.1186/s12883-017-0888-0.
citation: Bonnechere B, Jansen B, Omelina L, Van Sint Jan S. The use of commercial video games in rehabilitation: a systematic review. Int J Rehabil Res. 2016 Dec;39(4):277-290. doi: 10.1097/MRR.0000000000000190.