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

NCT ID: NCT05751122

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-25

Study Completion Date

2023-07-15

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dynamic flex cast with neurodevelopmental Group

Dynamic flex cast with neurodevelopmental treatment

Group Type EXPERIMENTAL

Dynamic flex cast with neurodevelopmental treatment

Intervention Type OTHER

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 Group

Rigid Ankle foot Orthosis with neurodevelopmental treatment

Group Type ACTIVE_COMPARATOR

Rigid Ankle foot Orthosis with neurodevelopmental treatment

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abrish Abbasi, MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Chal foundation, Bacha Khan Medical Complex

Swābi, KPK, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Nafisa Gul

Identifier Type: -

Identifier Source: org_study_id

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