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

July 23, 2023 updated by: Riphah International University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Swābi, KPK, Pakistan, 23430
        • Chal foundation, Bacha Khan Medical Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dynamic flex cast with neurodevelopmental Group
Dynamic flex cast with neurodevelopmental treatment
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.
Active Comparator: Rigid Ankle foot Orthosis with neurodevelopmental Group
Rigid Ankle foot Orthosis with neurodevelopmental treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Abrish Abbasi, MS-NMPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2023

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

July 15, 2023

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nafisa Gul

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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