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The Effects of Video Games in Stroke

Primary Purpose

Stroke, Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Commercial video game.
rehabilitation video game
Sponsored by
Universidad de Burgos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad de Burgos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Commercial video game

Rehabilitation video game

The control group

Arm Description

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

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

The control group received 30 minutes of conventional therapy

Outcomes

Primary Outcome Measures

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).
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 ).

Secondary Outcome Measures

Activities of daily living
The Functional Independence Measure (FIM-FAM) measure was used to evaluate the independence in the activities of daily living
Fulg Meyer Assessment (FMA)
The FMA was used to evaluated the upper limb function.
Box and Blocks test
The Box and Blocks test was used to evaluate the manual dexterity in both upper limbs.
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).

Full Information

First Posted
March 15, 2019
Last Updated
March 27, 2019
Sponsor
Universidad de Burgos
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1. Study Identification

Unique Protocol Identification Number
NCT03896542
Brief Title
The Effects of Video Games in Stroke
Official Title
The Efficacy of Video Game Therapy in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
February 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Burgos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Commercial video game
Arm Type
Experimental
Arm Description
the group commercial video game received 30 minutes of conventional therapy plus 30 minutes of rehab training using Xbox Kinect-based games.
Arm Title
Rehabilitation video game
Arm Type
Experimental
Arm Description
the group rehabilitation video game received 30 minutes of conventional therapy plus 30 minutes of rehab games.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
The control group received 30 minutes of conventional therapy
Intervention Type
Device
Intervention Name(s)
Commercial video game.
Intervention Description
Stroke patient had played with commercial video game, along 12 sessions.
Intervention Type
Device
Intervention Name(s)
rehabilitation video game
Intervention Description
Stroke patient had played with an specific video game for rehabilitation, along 12 sessions
Primary Outcome Measure Information:
Title
Strength
Description
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).
Time Frame
Change from baseline at post 12 sessions of intervention and follow-up four weeks after having finished the intervention.
Title
Range of motion
Description
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 ).
Time Frame
Change from baseline at post 12 sessions of intervention and follow-up four weeks after having finished the intervention.
Secondary Outcome Measure Information:
Title
Activities of daily living
Description
The Functional Independence Measure (FIM-FAM) measure was used to evaluate the independence in the activities of daily living
Time Frame
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.
Title
Fulg Meyer Assessment (FMA)
Description
The FMA was used to evaluated the upper limb function.
Time Frame
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.
Title
Box and Blocks test
Description
The Box and Blocks test was used to evaluate the manual dexterity in both upper limbs.
Time Frame
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.
Title
Muscle tone
Description
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).
Time Frame
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 Pre-specified Outcome Measures:
Title
The ID-Pain© the Lattineen Index.
Description
The ID-Pain was used to evaluate the pain.
Time Frame
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.
Title
Lattineen Index.
Description
The Lattineen Index was used to evaluate the pain.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Hilario Ortiz Huerta
Organizational Affiliation
Universidad de Burgos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Burgos
City
Burgos
ZIP/Postal Code
09004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28606661
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.
Results Reference
background
PubMed Identifier
24051993
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.
Results Reference
background
PubMed Identifier
25927099
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.
Results Reference
background
PubMed Identifier
27793071
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.
Results Reference
background
PubMed Identifier
28595611
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.
Results Reference
background
PubMed Identifier
27508968
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.
Results Reference
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The Effects of Video Games in Stroke

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