Effect of Neurodevelopmental treatment in improving function and participation of children with Diplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- - Canadian Occupational Performance Measure scale
研究概览
简要总结
Potential participants will be screened for eligibility criteria and after obtaining well-informed written consent of the parent(s) or legal guardian of the child, the child will be recruited as a participant. The participants will be distributed into experimental group/ group A (NDT and Home management program) and control group/ group B (Home management program only). Pre-intervention data will be collected using predetermined primary and secondary outcome measures. The planned intervention would be carried out for 10 weeks. NDT will be applied by trained therapists and parents will be trained to continue the home management program.
Experimental Group (Group A):
Participants will undergo NDT intervention including handling and facilitation during the activities of the day, 4 days a week for 10 weeks. Specific activation and strengthening will be done by the therapist and carry-over will be explained to parents who will continue the home management program.
Control Group (Group B):
Parents will be provided hands-on training on how to continue therapy at home for their children in a home management program. Parents and this group will receive 2/3 face-to-face interactions within 10 weeks of the study period with a trained therapist to check how the home management program is being carried out and to clarify any doubts or make additional suggestions.
Post-intervention data will be collected for both groups using the below-listed primary and secondary outcome measures.
Outcome measures:
Primary Outcome measure:
-
COPM scale
-
Child Engagement in daily life measure (Version 2)
-
GMFM-66
-
WeeFim
Secondary Outcome Measure:
-
Goal Attainment Scale
-
Pediatric balance scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diplegic Cerebral Palsy children aged between 5 to 12 years from Dehradun district with Gross motor classification system, manual ability classification system and communication function classification system as I-III.
排除标准
- •Other neurodevelopmental disorders like Down syndrome, metabolic disorders and genetic conditions.
- •Medical conditions or recurrent illness including seizures, respiratory disorder or dysphagia.
- •Any history of orthopedic/ neurological surgical procedures within 6 months before enrollment in the study.
结局指标
主要结局
- Canadian Occupational Performance Measure scale
时间窗: At the start of the study at the start of the study (1.8.2025 to 8 October 2025) | End of the study post 10 weeks of intervention methods.
- Child Engagement in daily life measure (Version 2)
时间窗: At the start of the study at the start of the study (1.8.2025 to 8 October 2025) | End of the study post 10 weeks of intervention methods.
- Gross Motor Function Measure-66
时间窗: At the start of the study at the start of the study (1.8.2025 to 8 October 2025) | End of the study post 10 weeks of intervention methods.
- Functional Independence Measure (Weefim)
时间窗: At the start of the study at the start of the study (1.8.2025 to 8 October 2025) | End of the study post 10 weeks of intervention methods.
次要结局
- Goal Attainment Scale(Pediatric Balance Scale)
研究者
Sandeep Khanna
Sardar Bhagwan Singh University