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临床试验 NCT06769178 针对脑瘫目前尚未招募。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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How Much Virtual Reality Intervention Improve the Balance of Patients with Cerebral Palsy 24 虚拟
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临床试验NCT06769178是一项针对脑瘫的干预性研究试验,当前状态为尚未招募。试验尚未开始,计划于2025年6月1日开始,预计招募24名患者。该研究由Yeditepe University主导,计划于2026年12月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年1月10日。
简要概括
The purpose of this clinical study is to investigate how effective virtual reality applications are in adult cerebral palsy rehabilitation.
The main questions it aims to answer are:
Do virtual reality interventions (of Becure Balance and Becure Wesense Systems) improve balance and is this improvement reflected in the clinic? Is there a change in brain functional resting state networks after virtual reality interven...
显示更多官方标题
Effect of Virtual Reality-Based Interventions on Clinical and Neuroplasticity, Brain Functional Resting State Networks in Cerebral Palsy Rehabilitation
疾病
脑瘫出版物
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
- SimayA
NCT编号
实际开始日期
2025-06
最近更新发布
2025-01-10
预计完成日期
2026-12
计划入组人数
24
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
adult cerebral palsy
functional magnetic reasonance imaging
virtual reality
becure systems
balance
resting state functional magnetic reasonance imaging
functional magnetic reasonance imaging
virtual reality
becure systems
balance
resting state functional magnetic reasonance imaging
主要目的
其他
分配方式
随机
干预模型
平行
盲法
单盲
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Serious Game Group BecureBalance and WesenseSystems will be used.Games'll be chosen to improve balance and empowerment,and game levels will be adjusted according to the condition of the participants.Balance Adventure is a game that involves transferring weight in 4 directions.At level 1,the goal is to reach the exit by collecting all the stars. At level 3,the goal is to collect stars on a moving surface and move the ball without droppi...显示更多 | Virtual Reality based Participants will receive treatment by a specialist physiotherapist for a total of 16 sessions, 2 days a week on non-consecutive days for 8 weeks. Both groups will receive neurodevelopmental treatment (NGT) for 16 sessions. While the control group will receive traditional balance training in each session, the VR group will play virtual reality-based games. |
其他Control Group Participants in the control group will receive a total of 16 sessions of structured NGT-based exercise applications prepared by the researchers.For this, involving balance and strengthening'll be applied, focusing mainly on lower extremity movements. For warm-up exercises, trunk rotation, shoulder rotation, hip rotation and toe-to-toe elevation and descent'll be performed for 10 minutes.Strengthening exercises'll mos...显示更多 | Virtual Reality based Participants will receive treatment by a specialist physiotherapist for a total of 16 sessions, 2 days a week on non-consecutive days for 8 weeks. Both groups will receive neurodevelopmental treatment (NGT) for 16 sessions. While the control group will receive traditional balance training in each session, the VR group will play virtual reality-based games. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Muscle Strength Assessment | Muscle strength is an important component of health. Muscle weakness is seen in the presence of neurologicaldiseases and therefore muscle strength measurement is important for general health assessment. The most common equipment or methods that provide quantitative measurements of strength, such as isokinetic and portable dynamometers, have been shown to provide valid and reliable measurements. The muscle strengths of the participants in the lower extremity (hip flexor, extensor, abductor and adductor, knee flexor and extensor, ankle dorsi-plantar flexor) muscle groups will be measured with a handheld dynamometer. | up to 8 weeks |
Timed Up and Go Test (TUG) | TUG is a rapid test used in clinic as an outcome measure to assess functional mobility as well as static and dynamic balance. It's based on the length of time which takes for an individual to get up from a chair, walk 3 meters at a comfortable (or fastest) pace, turn (or touch the wall), walk to chair and sit down again. | up to 8 weeks |
Berg Balance Scale (BBS) | The BBS, developed by Berg et al (1995) and used in the assessment of balance, is a four-point scale that rates patients' balance from easy to difficult (0: cannot do, 4: does independently). During the test consisting of 14 items, steps, rulers, stopwatches and chairs are used. The test evaluates postural control and fall risk. The maximum total score is 56 points. 0-20: high fall risk, 21-40: moderate fall risk, 41-56: low fall risk. The Turkish validity and reliability of the scale was made by Şahin et al (2008). | up to 8 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
fMRI scan | High-resolution (1 x 1 x 1 mm isotropic) sagittal 190 slices will be acquired with a T1-weighted imaging sequence (TR/TE: 7.7/3.7 ms;, FA: 8°; FOV: 256 x 256). Functional resting state data will be acquired with a single-shot echo planar imaging (EPI) sequence of 300 dynamic acquisitions consisting of 35 slices of 4 mm thickness (TR/TE: 2230/30 ms, FA: 77°; matrix: 80x80) and will last approximately 11 minutes. Magnetic field maps will be recorded in order to correct signal distortions caused by tissue inhomogeneities in the magnetic field during the analysis phase before functional acquisition. Participants will be asked to fix their gaze on a point by keeping their eyes open during functional acquisitions. Participants will be informed that they can close their eyes and rest during the other stages of the acquisitions. fMRI acquisitions will be completed in approximately 30 minutes, including the preparation stages. The MRI acquisition sequences will be as follows: Survey, Resting S | up to 8 weeks |
参与助手
资格标准
适龄参与研究
成人
最低年龄要求
18 Years
适龄性别
全部
Being diagnosed with unilateral spastic type cerebral palsy (hemiplegic type) / Being between the ages of 18-30 / Being able to walk independently (GMFCS I-II) / Not having Botox application in the last six months / Not using any medication that will affect the study process
Having a history of epileptic attacks / Having >2 spasticity in any joint according to the modified Ashworth scale / Having severe depression according to the Beck Depression Inventory /Having hearing-vision problems