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The Effects of Video Games in Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896542
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad de Burgos

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.


Condition or disease Intervention/treatment Phase
Stroke Hemiplegia Device: Commercial video game. Device: rehabilitation video game Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Video Game Therapy in Patients With Stroke
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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



Primary Outcome Measures :
  1. 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).

  2. 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 ).


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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).


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896542


Locations
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Spain
Universidad de Burgos
Burgos, Spain, 09004
Sponsors and Collaborators
Universidad de Burgos
Investigators
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Principal Investigator: J. Hilario Ortiz Huerta Universidad de Burgos

Publications:

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Responsible Party: Universidad de Burgos
ClinicalTrials.gov Identifier: NCT03896542    
Other Study ID Numbers: CEIC 1559
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms