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临床试验/CTRI/2024/05/067155
CTRI/2024/05/067155已完成2 期

Effectiveness of Parent Integrated Physiotherapeutic Approach (PIPTA) on gross motor function and balance in children with spastic diplegia:A Randomized Controlled Trial

NITTE Institute of Physiotherapy(NITTE Deemed to be University)1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年6月20日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Gross motor function measurement 88 (GMFM 88)

研究概览

简要总结

Studies show that Parent-delivered therapy helps children achieve better motor outcomes. Interventions given in home environment enhances motivation and engagement, and balances the effectiveness and compliance of children and care givers. Implementing task-oriented programmes at home produced improvement in performance with functional balance and the improvement persisted even after the training is completed.

Studies also suggest that with improvements in self-care and mobility of a CP child, there is reduction in physical strain of caring in caregivers. Being actively involved  in their child’s therapy reduces the emotional strain of caregivers.

Parent coaching is the key element of such interventions. In order to properly execute the intervention and understand its goal, parents and medical professionals must receive the necessary training and instruction. Applying a successful parent-delivered intervention requires reciprocal trusting relationships between the child, caregiver, and health care provider. By increasing connection and bonding time, a well-delivered parent-delivered intervention can improve the parent-child relationship which in turn develops the motor improvements in the child. Though parent delivered therapy improves the motor outcome of child, it can’t replace the expert health care professional care .There is scarce of evidence supporting an integrated strategy in which a therapist treats the child and involves parents in the treatment plan. There is also a lack of evidences for detailed description of working mechanism of an intervention that involves parents.  Also, there are fewer evidence that home therapy improved gross motor functions and balance outcomes. Therefore, the study intends to evaluate the effectiveness of `Parent Integrated Physio Therapeutic Approach’(PIPTA) on motor functions and balance on Children with Spastic Diplegia .This approach will include professional treatment, parent delivered home based program and parent education for environmental enrichment of the child to improve his functions.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Children diagnosed with Spastic Diplegia.
  • Children with either gender or age ranging from 5 to 12 years.
  • Children with GMFCS level I II and III.
  • Children who can follow verbal command with MMSE score above 30.

排除标准

  • Children with history of recurrent seizures.
  • Children who are under medications such as anti-epileptic and anti hypertensive drugs.
  • Children who underwent recent spinal or pelvic surgery
  • Children who have fixed spinal and ankle deformities.
  • Children who have cardiac anomalies.

结局指标

主要结局

Gross motor function measurement 88 (GMFM 88)

时间窗: Pre intervention (1st day) and post intervention (4th week) | Intervention period is 4 weeks followed by follow up after 2 weeks

Paediatric balance scale (PBS)

时间窗: Pre intervention (1st day) and post intervention (4th week) | Intervention period is 4 weeks followed by follow up after 2 weeks

次要结局

  • Depression, anxiety, stress scale 21 (DASS 21)-kannada version(Pre intervention (1st day) & post intervention (4th week))

研究者

发起方
NITTE Institute of Physiotherapy(NITTE Deemed to be University)
申办方类型
Other [Constituent Physiotherapy Institute of NITTE Deemed to be University]
责任方
Principal Investigator
主要研究者

Hiba Mariyam Azeem

Nitte Institute of Physiotherapy

研究点 (1)

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