Clinical trial NCT05903729: Task Oriented Activities Based on NDT Therapy Principles
Official title: Effects of Task Oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control and Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: CP, NDT therapy, task-oriented training, trunk control
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized control trial, used to compare conventional physiotherapt and neurodevelopmental therapy approaches on trunk control and upper extremity function in spastic diplegic cerebral palsy patients. subjects with spastic diplegic cerebral palsy meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique.
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is one of the primary causes of disability effecting majority of pediatric population. Cerebral Palsy is considered a neurological disorder caused by a non-progressive brain injury or malformation that occurs while the child's brain is under development. The worldwide incidence of cerebral palsy is it affects three to four individuals out of 1000 individuals in the general population. Cerebral palsy has different types depending upon the severity of disease or the area of the body it is affecting. Amongst the different types of CP, spastic diplegia is the most common type which mainly affects the lower extremities and lesser extent to upper extremities. It mainly affects functional performance and gait.

Detailed description: This study will be conducted on 20 subjects which would be equally divided into experimental and control groups. Trunk control measurement scale (TCMS) and quality of upper extremity skills test (QUEST) will be the tools used in this study. Pre and post values of the effects of intervention will be evaluated. The significance of this study is that it will help us how to improve trunk control and upper extremity function in spastic dipegic children. Data will be analyzed using SPSS 22.0. Mean and standard deviation will be calculated. Appropriate statistical test will be used after checking normality of data.

Eligibility criteria: Inclusion Criteria:

* • Children with spastic diplegic cerebral palsy with age between 6 to 12 years.

  * Children with spastic diplegic cerebral palsy who are able to follow verbal commands.
  * Children with spastic diplegic cerebral palsy having level II or III of gross motor function classification system.

Exclusion Criteria:

* • Children who are uncooperative and having neurological deficit.

  * Children with hearing deficit.
  * Children with epilepsy.
  * Children with cardiac anomalies which effect exercise tolerance.
  * Children having less than 6-month post-orthopedic surgery.
  * Children having less than 6-month post-botulinum toxin injection (BOTOX).

Primary outcomes:
measure: The trunk control measurement scale
timeFrame: 8 weeks
Secondary outcomes:
measure: The Quality of Upper Extremity Skills Test (QUEST)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ayesha tul Fatima, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sah AK, Balaji GK, Agrahara S. Effects of Task-oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control, Balance, and Gross Motor Function in Children with Spastic Diplegic Cerebral Palsy: A Single-blinded Randomized Clinical Trial. J Pediatr Neurosci. 2019 Jul-Sep;14(3):120-126. doi: 10.4103/jpn.JPN_35_19. Epub 2019 Sep 27.
citation: Talgeri AJ, Nayak A, Karnad SD, Jain P, Tedla JS, Reddy RS, Sangadala DR. Effect of Trunk Targeted Interventions on Functional Outcomes in Children with Cerebral Palsy- A Systematic Review. Dev Neurorehabil. 2023 Apr;26(3):193-205. doi: 10.1080/17518423.2023.2193265. Epub 2023 Apr 5.