跳至主要内容
临床试验/NCT03896542
NCT03896542已完成不适用

The Efficacy of Video Game Therapy in Patients With Stroke

Universidad de Burgos1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Strength

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Patients with unstable blood pressure or angina.
  • •History of seizures.
  • •Do not use video games

研究组 & 干预措施

The control group

No Intervention

The control group received 30 minutes of conventional therapy

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.

干预措施: 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.

干预措施: rehabilitation video game (Device)

结局指标

主要结局

Strength

时间窗: 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

时间窗: 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 ).

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验