The Effects of Video Games in Stroke

Not Applicable

Completed

• Conditions: Hemiplegia; Stroke
• Interventions: Device: Commercial video game.; Device: rehabilitation video game

• Registration Number: NCT03896542
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-02-20
• Status Verified: 2019-03
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Study First Posted: 2019-04-01
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Commercial video game	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.
Rehabilitation video game	rehabilitation video game	the group rehabilitation video game received 30 minutes of conventional therapy plus 30 minutes of rehab games.

Primary Outcome Measures

Name	Time	Method
Strength	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).
Range of motion	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

Name	Time	Method
Box and Blocks test	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.
Fulg Meyer Assessment (FMA)	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.
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.	The Functional Independence Measure (FIM-FAM) measure was used to evaluate the independence in the activities of daily living
Muscle tone	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).

Trial Locations

Locations (1)

Universidad de Burgos; 🇪🇸 Burgos, Spain