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临床试验/NCT06285877
NCT06285877Unknown不适用

Study on the Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury: A Pilot Study

Universidad Rey Juan Carlos1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
32
试验地点
1
主要终点
Fugl-Meyer

研究概览

简要总结

Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. The aim is to improve postural control in both seated and standing positions and to maintain and improve cognitive capacity.

Material and methods: one group (experimental group) will receive a total of 8 one-hour sessions or 16 half-hour sessions, depending on their individual needs, for 8 weeks using the Nintendo Switch. The other group (control group) will continue to receive their conventional scheduled therapy.

Measures: Abilhand, MEC-Lobo, FIST, Fugl-Meyer, Berg Balance Scale and CSQ-8.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Adult men and women, over 30 years of age who have suffered an acquired brain injury.
  • •Mild or moderate cognitive impairment as measured by the MEC-Lobo test (score greater than 23/35).
  • •Regularly attend some conventional therapy (neuropsychology, physiotherapy or occupational therapy).
  • •Agree to participate voluntarily by signing the informed consent form.

排除标准

  • •Present severe cognitive impairment as measured by the MEC-Lobo test (less than 23/35).
  • •Present aphasia of comprehension or expression.
  • •Present associated neurodegenerative pathology.
  • •Present any pathology underlying the acquired brain damage (diabetes, heart disease, COPD, etc.), heart disease, COPD, etc.).
  • •Voluntarily refuse to participate in the study.

研究组 & 干预措施

Control Group

Active Comparator

Control Group (CG) which received their usual sessions of conventional therapy.

干预措施: Conventional therapy sessions (Procedure)

Experimental Group

Experimental

Experimental Group (EG) which received therapy with Nintendo Switch plus their usual sessions of conventional therapy.

干预措施: Conventional therapy sessions plus Nintendo Switch (Procedure)

结局指标

主要结局

Fugl-Meyer

时间窗: Pre-intervention and post-intervention (up to 1-2 weeks)

This scale assesses the patient's motor function, sensory function, muscle balance, range of joint mobility and joint pain.

Abilhand

时间窗: Pre-intervention and post-intervention (up to 1-2 weeks)

It is an assessment test that measures the degree of difficulty perceived by the patient in performing the 23 activities of daily living.

Function in Sitting Test (FIST)

时间窗: Pre-intervention and post-intervention (up to 1-2 weeks)

It is a scale that assesses the postural control deficits presented by the patient in sedentary position in the event of imbalance, reaching on the floor, etc.

MEC-Lobo

时间窗: Pre-intervention and post-intervention (up to 1-2 weeks)

This is a scale that allows us to evaluate the cognitive status of patients. The lower the score, the greater the cognitive impairment.

Berg Balance Scale (BBS)

时间窗: Pre-intervention and post-intervention (up to 1-2 weeks)

The scale is used to measure balance mainly in standing position in patients with different types of pathologies.

次要结局

  • Client Satisfaction Questionnaire (CSQ-8)(Post-intervention (up to 1-2 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabel Quirosa Galan

Occupational Therapist, MsC

Universidad Rey Juan Carlos

研究点 (1)

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