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Clinical Trials/NCT03896542
NCT03896542CompletedNot Applicable

The Efficacy of Video Game Therapy in Patients With Stroke

Universidad de Burgos2 sites in 1 country45 target enrollmentStarted: July 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
2
Primary Endpoint
Strength

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Commercial video game

Experimental

the group commercial video game received 30 minutes of conventional therapy plus 30 minutes of rehab training using Xbox Kinect-based games.

Intervention: Commercial video game. (Device)

Rehabilitation video game

Experimental

the group rehabilitation video game received 30 minutes of conventional therapy plus 30 minutes of rehab games.

Intervention: rehabilitation video game (Device)

The control group

No Intervention

The control group received 30 minutes of conventional therapy

Outcomes

Primary Outcomes

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).

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

  • 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.)
  • 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.)
  • 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.)
  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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