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Core Stability in Ataxic Cerebral Palsied Children

Primary Purpose

Ataxic Cerebral Palsied Children, Core Stability, Balance and Coordination

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
core stability training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ataxic Cerebral Palsied Children focused on measuring Ataxia, humac balance sysytem, balance, coordination

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ataxic cerebral palsied children
  • must have level IV according to the gross motor function classification system.

Exclusion Criteria:

  • spastic cerebral palsied children
  • ataxia-telangiectasia
  • spinocerebellar ataxia
  • Joubert syndrome.
  • sensory ataxic

Sites / Locations

  • faculty of physical therapy Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

study group

Arm Description

received the selected physical therapy program for one hour, three times weekly for two successive months including facilitation of balance and protective reactions from kneeling, half kneeling and standing position, standing alone on balance board, standing on one leg, open gait training alone (walking on the balance beam, walking on the stepper and walking on wedges), training stair climbing, and strengthening of the back and abdominal muscles.

received the selected physical therapy program for one hour, three times weekly in addition to core stability training program for 30 minutes

Outcomes

Primary Outcome Measures

HUMAC Balance System
measuring Mobility Standing Balance Bilateral, stability standing balance bilateral, limit of stability and modified clinical test of sensory integration of balance Stabil
The Bruininks-Oseretsky Test of Motor Proficiency (bilateral coordination subtest)
measuring bilateral coordination with maximum score of the subtest 24 the higher scale score indicates better bilateral coordination
The Bruininks-Oseretsky Test of Motor Proficiency (upper limb coordination subtest)
measuring upper limb coordination with maximum score of the subtest 39 and higher sub test score indicate more upper limb coordination

Secondary Outcome Measures

Balance Error Scoring Systems scale
measuring balance with maximum score of the scale 60 the higher scale score indicated more balance loss and increased severity of the cases.
Scale for the Assessment and Rating of Ataxia
measuring severity of ataxia with maximum score of the scale 40 the higher score of the scale means sever affected ataxic child

Full Information

First Posted
March 25, 2021
Last Updated
March 31, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04823936
Brief Title
Core Stability in Ataxic Cerebral Palsied Children
Official Title
Effect of Core Stability on Balance and Coordination on Ataxic Cerebral Palsied Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

Brief Summary
Forty children with cerebellar ataxia ranged in age from five to nine years old, they were randomly assigned into two matched control and study groups. The control groups received the selected physical therapy program three times weekly one hour per session while the study group received core stability training for 30 minutes in addition to the selected physical therapy program. Both groups were evaluated by SARA Scale for the Assessment and Rating of Ataxia, Balance Error Scoring Systems scale, Bruininks-Oseretsky test of motor Proficiency 2ed subtest 4 (bilateral coordination), and subtest 7 (upper limb coordination), and HUMAC Balance System before and after two months of intervention.
Detailed Description
Forty ataxic cerebral palsied children were selected from private pediatric physical therapy centers, their ages ranged from five to nine years old. They were simply randomly assigned into two matched control and study group via an electronic program (SPSS) as illustrated in figure (1). The selected children had level IV according to the gross motor function classification system and their ataxia severity score was less than 25 according to the scale for the Assessment and Rating of Ataxia (SARA). Children have excluded it they had visual impairment, spasticity, uncontrolled convulsions, any other neuromuscular diseases, ataxia-telangiectasia, spinocerebellar ataxia, and Joubert syndrome. Measures Scale for the Assessment and Rating of Ataxia (SARA): it is a clinical scale that assesses a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test [22]. Balance Error Scoring Systems scale (BESS): This tool assesses postural control in stable surfaces the tests performed on the ground and foam block. It composes of six items performed with eyes closed taking 20 Sc each [23]. The Bruininks-Oseretsky Test of Motor Proficiency 2ed (BOT-2): It is a standardized, norm-referenced measure used by physical therapists and occupational therapists in the clinic and school practice settings. It is an individually administered test that delivers a most precise measure of motor skills, both gross and fine, of children and youth, 4 through 21 years of age [24]. HUMAC Balance System: Developed by Computer Sports Medicine, Inc. (CSMi), The HUMAC Balance System is a high-quality computerized balance system. It is a static force plate (Force Plate Mode) that measures Center of Pressure (COP) and Force [25]. 1- Procedures for evaluation Both groups were evaluated before and after two months of intervention by the SARA Scale for the Assessment and Rating of Ataxia, Balance Error Scoring Systems scale, Bruininks-Oseretsky test of motor Proficiency 2ed subtest 4 (bilateral coordination) and subtest 7 (upper limb coordination), and HUMAC Balance System. 2- Procedure for intervention The Control group received the selected physical therapy program for one hour, three times weekly for two successive months including facilitation of balance and protective reactions from kneeling, half kneeling and standing position, standing alone on balance board, standing on one leg, open gait training alone (walking on the balance beam, walking on the stepper and walking on wedges), training stair climbing, and strengthening of the back and abdominal muscles. The study group received the selected physical therapy program for one hour, three times weekly in addition to core stability training program for 30 minutes [26]. The core stability training program. illustration of core stability program. Supine abdominal draw in 10- 15 times Abdominal draw in with double knee to chest 10- 15 times Trunk twist while sitting on medical ball 10- 15 times Lying supine on the medical ball and rotating the trunk to the sides 10- 15 times Contracting abdominal muscles while lying in a supine position and pulling the limbs upward with arms and legs kept close 10- 15 times Bringing up the arms and legs simultaneously in the prone position 10- 15 times Bridging with head on medical ball hold this position for 3-5 s then slowly relaxes 10- 15 times Bridging while shoulders and hands are on the floor and one leg is raised 10- 15 times Lying supine on the medical ball and holding the abdomen in and bringing with one leg up 10- 15 times

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxic Cerebral Palsied Children, Core Stability, Balance and Coordination, Severity of the Ataxia
Keywords
Ataxia, humac balance sysytem, balance, coordination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
pre-test post-test randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
received the selected physical therapy program for one hour, three times weekly for two successive months including facilitation of balance and protective reactions from kneeling, half kneeling and standing position, standing alone on balance board, standing on one leg, open gait training alone (walking on the balance beam, walking on the stepper and walking on wedges), training stair climbing, and strengthening of the back and abdominal muscles.
Arm Title
study group
Arm Type
Active Comparator
Arm Description
received the selected physical therapy program for one hour, three times weekly in addition to core stability training program for 30 minutes
Intervention Type
Other
Intervention Name(s)
core stability training
Other Intervention Name(s)
selected physical therapy program
Intervention Description
core stability training program for 30 minutes including Supine abdominal draw in Abdominal draw in with double knee to chest Trunk twist while sitting on medical ball Lying supine on the medical ball and rotating the trunk to the sides Contracting abdominal muscles while lying in a supine position and pulling the limbs upward with arms and legs kept close Bringing up the arms and legs simultaneously in the prone position Bridging with head on medical ball hold this position for 3-5 s then slowly relaxes Bridging while shoulders and hands are on the floor and one leg is raised Lying supine on the medical ball and holding the abdomen in and bringing with one leg up
Primary Outcome Measure Information:
Title
HUMAC Balance System
Description
measuring Mobility Standing Balance Bilateral, stability standing balance bilateral, limit of stability and modified clinical test of sensory integration of balance Stabil
Time Frame
2 months
Title
The Bruininks-Oseretsky Test of Motor Proficiency (bilateral coordination subtest)
Description
measuring bilateral coordination with maximum score of the subtest 24 the higher scale score indicates better bilateral coordination
Time Frame
2 months
Title
The Bruininks-Oseretsky Test of Motor Proficiency (upper limb coordination subtest)
Description
measuring upper limb coordination with maximum score of the subtest 39 and higher sub test score indicate more upper limb coordination
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Balance Error Scoring Systems scale
Description
measuring balance with maximum score of the scale 60 the higher scale score indicated more balance loss and increased severity of the cases.
Time Frame
2 months
Title
Scale for the Assessment and Rating of Ataxia
Description
measuring severity of ataxia with maximum score of the scale 40 the higher score of the scale means sever affected ataxic child
Time Frame
2 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
boys and girls ranged in age from five to nine years old
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ataxic cerebral palsied children must have level IV according to the gross motor function classification system. Exclusion Criteria: spastic cerebral palsied children ataxia-telangiectasia spinocerebellar ataxia Joubert syndrome. sensory ataxic
Facility Information:
Facility Name
faculty of physical therapy Cairo university
City
Giza
ZIP/Postal Code
11111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Core Stability in Ataxic Cerebral Palsied Children

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