The Effects of Video Games in Stroke

Study Overview
=================
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.

Official Title
-----------------
The Efficacy of Video Game Therapy in Patients With Stroke

Conditions
-----------------
Stroke, Hemiplegia

Intervention / Treatment
-----------------
* Device: Commercial video game.
* Device: rehabilitation video game


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Commercial video game<br>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.<br>* Stroke patient had played with commercial video game, along 12 sessions.<br>|
| Experimental: Rehabilitation video game<br>the group rehabilitation video game received 30 minutes of conventional therapy plus 30 minutes of rehab games. | Device: rehabilitation video game<br>* Stroke patient had played with an specific video game for rehabilitation, along 12 sessions<br>|
| No Intervention: The control group<br>The control group received 30 minutes of conventional therapy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of daily living | 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) | 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 | 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 | 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. |