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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05751122
• Other study ID #: Nafisa Gul
• Status: Completed
• Phase: N/A
• Start date: February 25, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: July 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Dynamic flex cast with neurodevelopmental treatment
Neurodevelopmental therapy in combination with dynamic flex cast to treat experimental group. Three times a week, 1 hour session per day. Dynamic flex casting is casting which manipulate bone alignment and maintains range of motion or sustained stretch. Casting will be changed weekly for 3 months. Neuro developmental approach is individualized treatment which is attuned to each child's specific problems, aims and goals. Key elements in NDT are: facilitation (using sensory inputs to improve motor performance), management of compensatory motor behavior, and an overall management strategy (a 24-hour interdisciplinary management approach) NDT involves task specific postures and movements.
• Rigid Ankle foot Orthosis with neurodevelopmental treatment
Rigid ankle foot orthosis will be applied to ankle joint at the start of intervention. Neurodevelopmental treatment will be applied to both groups with protocol; Three times a week, 1 hour session per day. Assessment on 1st day,6th week and 12th week

Locations

Country	Name	City	State
Pakistan	Chal foundation, Bacha Khan Medical Complex	Swabi	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measure-88	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.	12 weeks
Primary	Clinical Gait Assessment Scale	It is used to assess gait deviation. Temporal distance factors including velocity, cadence, stride length, stride width will be assessed.	12 weeks