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NCT Number: NCT05751122

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chal foundation, Bacha Khan Medical Complex

Swābi, KPK, 23430, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic flex cast with neurodevelopmental treatment

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 treatment

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

Primary outcomes

  1. Gross Motor Function Measure-88

    Time frame: 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.

  2. Clinical Gait Assessment Scale

    Time frame: 12 weeks

    It is used to assess gait deviation. Temporal distance factors including velocity, cadence, stride length, stride width will be assessed.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2023
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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