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Clinical Trials/NCT05707052
NCT05707052
Recruiting
Not Applicable

Comparative Effects of Neck-Trunk Stabilization Exercises and Bobath Therapy on Trunk Control and Upper Limb Function in Children With Spastic Diplegic Cerebral Palsy: A Randomized Clinical Trial

Riphah International University1 site in 1 country44 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy Spastic Diplegia
Sponsor
Riphah International University
Enrollment
44
Locations
1
Primary Endpoint
Manual Ability Classification System (MACS)
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Physiotherapy is widely used in the treatment of children with cerebral palsy. This study is conducted to identify the most appropriate physiotherapy approach. The purpose of the study is to compare two physical rehabilitation strategies i.e., Neck-trunk stabilization exercises and Bobath therapy, to investigate their effectiveness on trunk control and upper limb function. The aims of treatment are to influence muscle tone and improve postural alignment by specific handling technique.

Detailed Description

The study will be a Randomized Clinical Trial conducted at the physiotherapy outpatient clinic of the tertiary care hospital in Sialkot, Idrees Hospital. Following the approval of the BASR, the study will be completed within six months. The sample will be taken using a non-probability convenient sampling technique, and the sample will be randomly divided into two groups. A sample size of 44 patients will be taken in this study. There will be two groups. Both groups will receive conventional therapy consisting of stretching, strengthening, range-of-motion exercises, positioning, and electrical stimulation. Group A: This group will receive Neck-Trunk Stabilization exercises. Group B: This group will receive Bobath therapy. The total intervention protocol will be given for six weeks' duration, with three sessions per week of about 45 minutes each. Outcome measures tools will be Segmental Assessment of Trunk Control (SATCo) and Manual Ability Classification System (MACS). Children with spastic diplegic cerebral palsy will be measured at baseline and after 6 weeks.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
March 22, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children diagnosed with spastic diplegic cerebral palsy
  • Children with score of GMFCS \[2\] \[3\] \[4\] levels(2, 16).
  • Signed consent form from parents/guardians.

Exclusion Criteria

  • Children with visual impairments
  • Children with major auditory impairments
  • Children with previous orthopedic surgery and Botulium toxin-A injection at least for 6 months
  • Children having pharmacological intervention for the inhibition of spasticity
  • Contractures
  • Uncontrolled seizures
  • Focal spasticity

Outcomes

Primary Outcomes

Manual Ability Classification System (MACS)

Time Frame: 4th week

Changes from baseline MACS as been used to classify how children with cerebral palsy use their hands when handling objects in daily activities.it is designed to reflect the typical manual performance of child. The ability of children from 4 - 18 years old with cerebral palsy to handle objects in everyday activities can be categorized into 5 levels.

Segmental Assessment of Trunk Control (SATCo)

Time Frame: 4th week

Changes from baseline SATCo provides a systematic method of assessing discrete levels of trunk control in children with motor disabilities. The SATCo determines the topmost (most cephalo) segment at which control of the upright posture is poor or not demonstrated i.e. is currently being learned for each of static, active and reactive control.

Study Sites (1)

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