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临床试验/CTRI/2024/05/066622
CTRI/2024/05/066622尚未招募不适用

Effect of Task-oriented training based on neurodevelopment therapy principle on gait and functional activities of daily living in cerebral palsy

Galgotias University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
102
试验地点
1
主要终点
Motion analysis tool (Gaiton)

研究概览

简要总结

Cerebral palsy (CP) is a group of non-progressive motor disorders caused by damage to the developing brain, primarily affecting movement and posture(1). It is one of the most common physical disabilities affecting children worldwide, with a prevalence of approximately 2.11 per 1000 live births(2). Children with cerebral palsy often experience significant impairments in gait, leading to decreased functional independence and reduced quality of life. Gait abnormalities in CP can manifest as alterations in stride length, step width, velocity, and overall gait pattern(3,4).

 Cerebral palsy is a complex and heterogeneous neurological condition that affects movement and posture. It is caused by abnormal brain development or damage to the brain, occurring either during pregnancy, childbirth, or the early years of life(5). This non-progressive disorder manifests in various motor impairments, including muscle stiffness, involuntary movements, muscle weakness, and coordination difficulties. Individuals with cerebral palsy may also experience associated conditions, such as intellectual disabilities, epilepsy, communication challenges, and sensory impairments(6). The severity of the condition can vary significantly from person to person, with some individuals being mildly affected, while others may have more severe and profound impairments(7).

 The four main types of cerebral palsy are spastic, dyskinetic, ataxic, and mixed, each characterized by specific movement patterns and affected body parts. Spastic cerebral palsy, the most common type, is marked by increased muscle tone and stiffness, leading to limited joint movement and muscle control(8). Dyskinetic cerebral palsy involves uncontrollable and involuntary movements, affecting both gross and fine motor skills. Ataxic cerebral palsy results in problems with balance and coordination, leading to shaky movements and difficulty performing precise motor tasks. Mixed cerebral palsy is a combination of two or more types of movement disorders, resulting in a wide range of symptoms and challenges.

 The exact cause of cerebral palsy remains unclear in many cases, although several risk factors have been identified. These include premature birth, low birth weight, multiple pregnancies, maternal infections during pregnancy, and brain injuries from oxygen deprivation during childbirth. Early diagnosis and intervention are crucial for managing cerebral palsy effectively. Therapeutic approaches like physical therapy, occupational therapy, and speech therapy aim to improve mobility, motor skills, and communication abilities. Medications may also be prescribed to manage spasticity, alleviate pain, or control associated conditions like seizures. In more severe cases, surgical interventions might be necessary to address specific orthopaedic issues

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Age Range: Children and adolescents aged between 5 and 12 years.
  • Diagnosis: Participants must have a confirmed diagnosis of cerebral palsy by a qualified medical professional.
  • Type of Cerebral Palsy: Children and adolescents with any type of cerebral palsy (spastic, dyskinetic, ataxic, or mixed) are eligible for inclusion.
  • Gait Impairment: Individuals should exhibit gait abnormalities, such as altered stride length, step width, or gait velocity, that affect their functional mobility.
  • Ability to Walk: Participants must be capable of walking independently or with the use of assistive devices, such as walkers or crutches.
  • Medical Stability: Individuals should be medically stable and free from any acute medical conditions that could interfere with participation in the training program.
  • Ability to Follow Instructions: Participants should have the cognitive and communicative ability to understand and comply with the instructions during the training sessions.

排除标准

  • Severe Cognitive Impairment: Participants with severe cognitive impairments or intellectual disabilities that would hinder their ability to actively participate in the task-oriented training program will be excluded.
  • Severe Communication Difficulties: Individuals with significant communication difficulties, making it challenging to understand or follow instructions during the training sessions, will be excluded.
  • Uncontrolled Medical Conditions: Participants with uncontrolled medical conditions, such as uncontrolled seizures or active infections, that could compromise their safety or interfere with the study outcomes will be excluded.

结局指标

主要结局

Motion analysis tool (Gaiton)

时间窗: 8 week

次要结局

  • The Functional Mobility Scale (FMS)(8 week)

研究者

发起方
Galgotias University
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Narendra Kumar

Galgotias university

研究点 (1)

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