NCT04823936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 25, 2021

Last Update Submit

March 31, 2021

Conditions

Keywords

Ataxiahumac balance sysytembalancecoordination

Outcome Measures

Primary Outcomes (3)

  • 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

    2 months

  • 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

    2 months

  • 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

    2 months

Secondary Outcomes (2)

  • Balance Error Scoring Systems scale

    2 months

  • Scale for the Assessment and Rating of Ataxia

    2 months

Study Arms (2)

control group

NO INTERVENTION

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.

study group

ACTIVE COMPARATOR

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

Other: core stability training

Interventions

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

Also known as: selected physical therapy program
study group

Eligibility Criteria

Age5 Years - 9 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsboys and girls ranged in age from five to nine years old
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Giza, 11111, Egypt

Location

MeSH Terms

Conditions

Ataxia

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: pre-test post-test randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of physical therapy Faculty of Physical Therapy Cairo University

Study Record Dates

First Submitted

March 25, 2021

First Posted

April 1, 2021

Study Start

October 1, 2018

Primary Completion

September 30, 2020

Study Completion

February 28, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations