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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05903729
Other study ID # REC/RCR & AHS/23/0711
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2023
Est. completion date September 15, 2023

Study information

Verified date November 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 15, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Neurodevelopmental therapy treatment
The group will receive NDT therapy
conventional physiotherapy
conventional physiotherapy

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The trunk control measurement scale The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy. 8 weeks
Secondary The Quality of Upper Extremity Skills Test (QUEST) The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. 8 weeks
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