The Effects of Video Games in Stroke

March 27, 2019 updated by: Universidad de Burgos

The Efficacy of Video Game Therapy in Patients With Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Burgos, Spain, 09004
        • Universidad de Burgos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Commercial video game
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.
Stroke patient had played with commercial video game, along 12 sessions.
EXPERIMENTAL: Rehabilitation video game
the group rehabilitation video game received 30 minutes of conventional therapy plus 30 minutes of rehab games.
Device: rehabilitation video game
Stroke patient had played with an specific video game for rehabilitation, along 12 sessions
NO_INTERVENTION: The control group
The control group received 30 minutes of conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength
Time Frame: Change from baseline at post 12 sessions of intervention and follow-up four weeks after having finished the intervention.
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
Time Frame: Change from baseline at post 12 sessions of intervention and follow-up four weeks after having finished the intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Fulg Meyer Assessment (FMA)
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.
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.
Box and Blocks test
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.
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.
Muscle tone
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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ID-Pain© the Lattineen Index.
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.
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.
Lattineen Index.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Burgos

Investigators

  • Principal Investigator: J. Hilario Ortiz Huerta, Universidad de Burgos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

February 20, 2018

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (ACTUAL)

April 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC 1559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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