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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dynamic flex cast with neurodevelopmental treatment
Rigid Ankle foot Orthosis with neurodevelopmental treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Ankle joint, Cerebral Palsy, Spasticity, Dynamic cast

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chal foundation, Bacha Khan Medical Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dynamic flex cast with neurodevelopmental Group

Rigid Ankle foot Orthosis with neurodevelopmental Group

Arm Description

Dynamic flex cast with neurodevelopmental treatment

Rigid Ankle foot Orthosis with neurodevelopmental treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
July 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05751122
Brief Title
Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Cerebral Palsy
Official Title
Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 25, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Ankle joint, Cerebral Palsy, Spasticity, Dynamic cast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic flex cast with neurodevelopmental Group
Arm Type
Experimental
Arm Description
Dynamic flex cast with neurodevelopmental treatment
Arm Title
Rigid Ankle foot Orthosis with neurodevelopmental Group
Arm Type
Active Comparator
Arm Description
Rigid Ankle foot Orthosis with neurodevelopmental treatment
Intervention Type
Other
Intervention Name(s)
Dynamic flex cast with neurodevelopmental treatment
Intervention Description
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
Intervention Name(s)
Rigid Ankle foot Orthosis with neurodevelopmental treatment
Intervention Description
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 Outcome Measure Information:
Title
Gross Motor Function Measure-88
Description
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.
Time Frame
12 weeks
Title
Clinical Gait Assessment Scale
Description
It is used to assess gait deviation. Temporal distance factors including velocity, cadence, stride length, stride width will be assessed.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abrish Abbasi, MS-NMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chal foundation, Bacha Khan Medical Complex
City
Swābi
State/Province
KPK
ZIP/Postal Code
23430
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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