The Effects of Video Games in Stroke

NCT03896542 | Completed DMC

• 1 other identifier: CEIC 1559
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiplegia

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• 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.

• Fulg Meyer Assessment (FMA)

  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.

• Box and Blocks test

  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.

• Muscle tone

  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 (2)

• The ID-Pain© the Lattineen Index.

  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.

• Lattineen Index.

  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.

Study Arms (3)

Commercial video game

EXPERIMENTAL

the group commercial video game received 30 minutes of conventional therapy plus 30 minutes of rehab training using Xbox Kinect-based games.

Device: Commercial video game.

Rehabilitation video game

EXPERIMENTAL

the group rehabilitation video game received 30 minutes of conventional therapy plus 30 minutes of rehab games.

Device: rehabilitation video game

The control group

NO INTERVENTION

The control group received 30 minutes of conventional therapy

Interventions

Commercial video game. DEVICE

Stroke patient had played with commercial video game, along 12 sessions.

Commercial video game

rehabilitation video game DEVICE

Stroke patient had played with an specific video game for rehabilitation, along 12 sessions

Rehabilitation video game

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Burgos: lead

Study Sites (1)

Universidad de Burgos

Burgos, 09004, Spain

Location

Related Publications (6)

• 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.

  PMID: 28606661 BACKGROUND

• 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.

  PMID: 24051993 BACKGROUND

• 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.

  PMID: 25927099 BACKGROUND

• 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.

  PMID: 27793071 BACKGROUND

• 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.

  PMID: 28595611 BACKGROUND

• 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.

  PMID: 27508968 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• J. Hilario Ortiz Huerta

  Universidad de Burgos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: April 1, 2019
• Study Start: July 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: February 20, 2018
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)