AzTrials
AzTrials

Ataxic Cerebral Palsied ChildrenNCT04823936

Core Stability in Ataxic Cerebral Palsied Children

A study testing core stability training in people with Ataxic Cerebral Palsied Children and Core Stability, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 5 to 9 years
What is being tested?
core stability training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Oct 2018to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • faculty of physical therapy Cairo university

    Giza, 11111

Other trials in Egypt

About this study

Official title: Effect of Core Stability on Balance and Coordination on Ataxic Cerebral Palsied Children

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.

Read the 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

  1. 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].
  2. 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].
  3. 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].
  4. 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

Being tested
core stability training
Keywords
Ataxia, humac balance sysytem, balance, coordination
Medical subject headings
Ataxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • core stability trainingOther

    Also called selected physical therapy program

    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

Study groups in NCT04823936
Study groupRoleWhat they receive
control groupNo interventionreceived 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.
study groupActive comparatorreceived the selected physical therapy program for one hour, three times weekly in addition to core stability training program for 30 minutes
Receives: Other: core stability training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 months

  2. 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

    Measured: 2 months

  3. 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

    Measured: 2 months

Secondary outcomes (2)
  1. 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.

    Measured: 2 months

  2. 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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start1 Oct 2018
  3. Primary completion30 Sep 2020
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
pre-test post-test randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04823936
Sponsor's protocol ID
Faculty of Physcial therapy
Status last verified
Mar 2021
First submitted
25 Mar 2021
Last updated
1 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing core stability training in people with Ataxic Cerebral Palsied Children and Core Stability, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HUMAC Balance System (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in