The Effects of Video Games in Stroke

Stroke Clinical Trial

Official title:

The Efficacy of Video Game Therapy in Patients With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896542
• Other study ID #: CEIC 1559
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: February 20, 2018

Study information

• Verified date: March 2019
• Source: Universidad de Burgos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 20, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Device:
• Commercial video game.
Stroke patient had played with commercial video game, along 12 sessions.
• rehabilitation video game
Stroke patient had played with an specific video game for rehabilitation, along 12 sessions

Locations

Country	Name	City	State
Spain	Universidad de Burgos	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Burgos

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Bonnechère 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. Review. — View 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. — View Citation

Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;(2):CD008349. doi: 10.1002/14651858.CD008349.pub3. Review. Update in: Cochrane Database Syst Rev. 2017 Nov 20;11:CD008349. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The ID-Pain© the Lattineen Index.	The ID-Pain was used to evaluate the pain.	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	Lattineen Index.	The Lattineen Index was used to evaluate the pain.	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.
Primary	Strength	The microFET 2© dynamometer had been used in order to evaluate the strength in several muscle groups: Shoulder (flexion and extension, adduction and abduction, internal and external rotation), elbow (flexion and extension, supination and pronation), wrist (flexion and extension).	Change from baseline at post 12 sessions of intervention and follow-up four weeks after having finished the intervention.
Primary	Range of motion	The goniometer had been used in order to evaluate the range motion. Joints: Shoulder (flexion and extension, adduction and abduction, internal and external rotation), elbow (flexion and extension, supination and pronation), wrist (flexion and extension, ulnar and radial deviation ).	Change from baseline at post 12 sessions of intervention and follow-up four weeks after having finished the intervention.
Secondary	Activities of daily living	The Functional Independence Measure (FIM-FAM) measure was used to evaluate the independence in the activities of daily living	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.
Secondary	Fulg Meyer Assessment (FMA)	The FMA was used to evaluated the upper limb function.	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.
Secondary	Box and Blocks test	The Box and Blocks test was used to evaluate the manual dexterity in both upper limbs.	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.
Secondary	Muscle tone	The Modified Ashworth scale has been used to evaluate the muscle tone. Muscle groups evaluated: Shoulder (flexion and extension, adduction and abduction, internal and external rotation), elbow (flexion and extension, supination and pronation), wrist (flexion and extension).	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.