Neck-Trunk Stabilization Exercises and Bobath Therapy Spastic Diplegic Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Cerebral Palsy Spastic Diplegia

• Registration Number: NCT05707052
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-01-22
• Study First Submitted QC: 2023-01-22
• Last Update Submitted: 2023-01-22
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Manual Ability Classification System (MACS)	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)	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.

Trial Locations

Locations (1)

Idrees Hospital; 🇵🇰 Sialkot, Punjab, Pakistan