Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Dynamic flex cast with neurodevelopmental treatment; Other: Rigid Ankle foot Orthosis with neurodevelopmental treatment

• Registration Number: NCT05751122
• Lead Sponsor: Riphah International University

Brief Summary

The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy.

Detailed Description

The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. Combination of Dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to improve gross motor functions in cerebral palsy. We shall try to fill the gaps of previous studies. It will help in facilitating children to perform their activities, restoring normal ranges and treatment of spasticity in cerebral palsy.

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study Start: 2023-02-25
• Study First Posted: 2023-03-02
• Status Verified: 2023-07
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15
• Last Update Submitted: 2023-07-23
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children with cerebral palsy
• Age 3-8 years
• Spastic diplegic/ hemiplegic CP
• Ankle dorsiflexion 5-10 degrees
• GMFCS level 1-3
• Modified Ashworth's scale level 1+ - 3

Exclusion Criteria

• Congenital foot deformities
• Cognitive impairments
• Secondary orthopedic, auditory and severe visual impairments
• Unwilling patients or parents
• Recent surgical interventions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dynamic flex cast with neurodevelopmental Group	Dynamic flex cast with neurodevelopmental treatment	Dynamic flex cast with neurodevelopmental treatment
Rigid Ankle foot Orthosis with neurodevelopmental Group	Rigid Ankle foot Orthosis with neurodevelopmental treatment	Rigid Ankle foot Orthosis with neurodevelopmental treatment

Primary Outcome Measures

Name	Time	Method
Clinical Gait Assessment Scale	12 weeks	It is used to assess gait deviation. Temporal distance factors including velocity, cadence, stride length, stride width will be assessed.
Gross Motor Function Measure-88	12 weeks	The original GMFM has 88 items each scored on a 4-point ordinal scale of 0 to 3, where 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes \< 10% activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of activity); 3 indicates that the child completes the task (100%); and NT indicates that the child was not tested. The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. Reliability with intraclass correlation coeffcient greater than .98 with 0.965--.994 95% confidence interval.

Trial Locations

Locations (1)

Chal foundation, Bacha Khan Medical Complex; 🇵🇰 Swābi, KPK, Pakistan