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Completed

NCT Number: NCT03896542

The Effects of Video Games in 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Burgos

Burgos, 09004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Commercial video game.

Device

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

rehabilitation video game

Device

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad de Burgos

Other

Registry information

Official study title

The Efficacy of Video Game Therapy in Patients With Stroke

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 1, 2019
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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