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临床试验 NCT05557305 针对痉挛性脑瘫，痉挛性半身不遂目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Changes in Motor and Cognitive Function on Unilateral Spastic Cerebral Palsy, Associated With Videogame Therapy 84 随机化 虚拟
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临床试验NCT05557305是一项针对痉挛性脑瘫，痉挛性半身不遂的干预性研究试验，目前试验状态为招募中。试验始于2022年12月22日，计划招募84名患者。该研究由Universidad Nacional Autonoma de Mexico主导，预计于2025年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年5月7日。
简要概括
The use of interactive applications associated with position and movement sensors has begun to spread as an option for the reinforcement of physical rehabilitation therapies in patients with congenital or acquired motor disorders as a result of some neurological damage, due to its portability and the relative autonomy granted to the patient. However, the results of its effectiveness and impact continue to be scarce c...显示更多
详细描述
This intervention protocol aims to validate five interactive applications for neurorehabilitation, as an effective therapeutic complement for the rehabilitation of children with unilateral cerebral palsy, compared to conventional rehabilitation.
The intervention contemplates first a phase of application of standardized tests in the Cognitive enablement lab of the National Institute of pediatrics (INP) in Mexico City...
显示更多官方标题
Evaluation of the Usability, Safety, and Possible Beneficial Effects on Motor and Cognitive Functions Associated With Using a Neuro-rehabilitation Platform With Video Games in Pediatric Patients With Unilateral Spastic Cerebral Palsy
疾病
痉挛性脑瘫痉挛性半身不遂出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- 2022/054
NCT编号
实际开始日期
2022-12-22
最近更新发布
2024-05-07
预计完成日期
2025-12
计划入组人数
84
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
virtual rehabilitation
video games
motor function
spastic hemiparesis
cerebral palsy
unilateral spastic cerebral palsy
video games
motor function
spastic hemiparesis
cerebral palsy
unilateral spastic cerebral palsy
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Videogame therapy The participants of the experimental group will only undergo video game therapy and will be called twice a week to perform supervised video game rehabilitation therapy, for a period of 45-50 minutes per session, for 10 weeks | Videogame therapy There will be 5 video game-type applications for virtual therapy, each with a specific therapeutic objective, which will be administered by trained personnel, depending on the characteristics of each patient. |
阳性对照Conventional therapy The participants in the control group will undergo the conventional therapy prescribed by their treating physician, at the INP they are prescribed occupational therapy, which is usually focused on game activities with balls, dice, cubes, tying ropes, etc., twice a week for 10 weeks. | 常规治疗 Occupational therapy with different play materials |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in the Fugl-Meyer Assesment for upper extremity (FMUE) | Level of motor deficit, evaluated using the Fugl-Meyer Assessment scale for the upper limb (0-66), with 66 meaning no defficit. | Baseline, 10 Weeks, 6 months |
Change in the Quality of Upper Extremity Skills Test (QUEST) | Upper limb motor skill level, obtained through the Quality of Upper Extremity Skills Test (less than 0 to 100), with 100 being the best quality of movement. | Baseline, 10 Weeks, 6 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in the PedsQl pediatric quality of life questionnaire | Level of independence in performing activities of daily living (ADLs), assessed using the PedsQl pediatric quality of life questionnaire (0-132) with 0 as the highest score. | Baseline, 10 Weeks, 6 months |
Change in the digital version of the Trail Making Test (TMT-A) | Changes in cognitive function in terms of speed of executive functions and attention, measured by a digitized version of the Trail Making Test A. | Baseline, 10 Weeks, 6 months |
Change in the digital version of the Corsi cube test. | Changes in working memory measured by the Corsi Cubes test. | Baseline, 10 Weeks, 6 months |
Change in the digital version of the Perception of differences test (FACES) | Changes in visual perception, using the perception of differences test | Baseline, 10 Weeks, 6 months |
Change in the Digital implementation of the Go-NoGo paradigm. | Changes in inhibition and flexibility functions, measured using a digital implementation of the Go-NoGo paradigm | Baseline, 10 Weeks, 6 months |
参与助手
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
5 Years
适龄性别
全部
- Outpatients
- Both genders
- Reside in Mexico City and the metropolitan area
- Between 5 and 18 years old
- With upper extremity hemiparesis caused by Unilateral Spastic Cerebral Palsy (USCP) on their dominant side or not
- Who are at levels I-III of the Manual Ability Classification System for Children with Cerebral Palsy (MACS)
- Score equal to or greater than 20 on the Fugl-Meyer upper extremity scale.
- Patients with joint instability (shoulder, elbow, or wrist)
- With severe concomitant medical problems such as congestive heart failure or seizures that prevent adequate attention to the task.
- Severe aphasia
- Hemineglect
- Visual disturbances that are not corrected with glasses
- Uncompensated hearing impairment
- Inability to understand instructions (Token Test < 17)
- Patients receiving concurrent therapies.
Universidad Nacional Autonoma de MexicoNational Institute of Pediatrics, Mexico研究责任方
Ana María Escalante Gonzalbo, 主要研究者, Head of the Laboratory of neurorehabilitation (LANR) IFC, UNAM, Universidad Nacional Autonoma de Mexico
研究中心联系人
联系人: Ana María Escalante-Gonzalbo, MCompSci, 525556225730, [email protected]
联系人: Eduardo Espinosa-Garamendi, PhD, 525635280056, [email protected]
1 位于 1 个国家/地区的研究中心
Coyoacán, CDMX
Instituto Nacional de Pediatría, Mexico City, Coyoacán, CDMX, 04530, Mexico
Ana Maria Escalante-Gonzalbo, MCSc, 联系人, 5556225730, [email protected]
招募中