Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202003569302150 Date of Approval: 27/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Physical Therapy Program on Vestibular Function in Children with Hearing Impairment
Official scientific title Effect of Physical Therapy Program on Vestibular Function in Children with Hearing Impairment
Brief summary describing the background and objectives of the trial The development of balance and coordination are intimately related and dependent on inputs from the vestibular, visual, proprioceptive and motor systems .Since vestibular function plays an important role in the development of balance and locomotion, impairment of the vestibulospinal system in infancy may lead to delayed achievement of balance and coordination .the aim of the study-to assess effectiveness of physical therapy program on vestibular function in children with hearing impairment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 25/03/2019
Actual trial start date 25/04/2019
Anticipated date of last follow up 24/06/2019
Actual Last follow-up date 25/02/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 34
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
protocol number 40 p.t.rec/012/002587
p.t.rec/012/002587
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group trampoline ex according to child tolerance three times per week for tow MONTHS 1 Jump up and down on the trampoline. 2 Jumping on trampoline and rotate in clockwise direction. 3 Jumping on trampoline and rotate to right side counter clockwise direction. 5
Experimental Group Balance exercises 25 mint three times per week for tow MONTHS 1 step stand over balance board alone. 2 stand over balance board one leg alone. 3 hoping reaction 4 half kneeling on balance board 5 tandem gait 7
Experimental Group Peripheral vestibular stimulation exercises EACH EX .10 REPETITION THREE TIMES PER WEEK FOR TOW MONTHS 1 Ask the child to move his/her head horizontally with diļ¬€erent speeds while he/she is looking at a target in front for 1 minute. Now ask him/her to move his/her head vertically. 10 times 2 Ask the child to look at his/her thumb while he/ she is moving his head and trunk together on a rotational chair. 10 times 3 Ask the child to look at a target on a wall while walking, moving his/her head horizontally for 15 seconds. Then ask him/her to do it while he/she is moving his/ her head vertically. 10 times 4 Put 2 targets horizontally in front of a child on the wall. Ask him to look at one target for 10 seconds. Afterward, ask him to look at the next target with head fixed. Now ask him/ her to move his head toward the second target. Then Now put the targets vertically and repeat the exercise. Ask the child to do it faster time by time 10 times NB: all exercises applied according to patient to tolerance. rest in case of signs and symptoms vestibular over stimulation. orders of exercise according to patient tolerance. 5
Control Group DAILY ACTIVITIES ONE HOUR THREE TIMES PER WEEK FOR TOW MONTHS ALL DAILY LIVING ACTIVITIES 17 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Children aged between 10 and 14 years. - With profound hearing impairment. - Ability to understand simple instructions by sign language. - Can Stand and walk independently. - Any cognitive impairments e.g. attention deficit hyperactive disorder (ADHD). - Blindness. - Cochlear implantation. - Neurological impairments e. g like cerebral palsy, downs syndrome. - Orthopedic impairments e. g like foot deformities, congenital hip dislocations. - Cardiovascular condition as congenital heart diseases. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 10 Year(s) 14 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/01/2020 Effect of Physical Therapy Program on Vestibular Function in Children with Hearing Impairment
Ethics Committee Address
Street address City Postal code Country
street between chateaux / University of Cairo / Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improve balance. After three month
Secondary Outcome IMPROVE QUALITY OF LIFE AFTER FINISHING TREATMENT PROGRAME
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Amal School for the Deaf and the Hearing Impaired children 10 Ramadan street Bani mazar Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
osama yassin abass SHARQUEE ST BANI MAZAR 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faten Street between chateaux / University of Cairo / Giza Giza 12613 Egypt Individual
Secondary Sponsor Mohamed Ali Street between chateaux / University of Cairo / Giza Giza 12613 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Faten Street between chateaux / University of Cairo / Giza Giza 12613 Egypt
Mohamed Ali Street between chateaux / University of Cairo / Giza Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Hassen faten.hassan@pt.cu.edu.eg 002737617691 Street between chateaux / University of Cairo / Giza
City Postal code Country Position/Affiliation
Giza 12613 Egypt PROF
Role Name Email Phone Street address
Public Enquiries Mohamed Ali elrahmapt@gmail.com 002737617691 Street between chateaux / University of Cairo / Giza
City Postal code Country Position/Affiliation
Giza 12613 Egypt prof
Role Name Email Phone Street address
Scientific Enquiries Faten Hassen faten.hassan@pt.cu.edu.eg 002737617691 Street between chateaux / University of Cairo / Giza
City Postal code Country Position/Affiliation
Giza 12613 Egypt prof
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Age from 10 y-14 y GENDER :19 M- 15 F Study Protocol START FROM 25 APRIL 2019 ENDED AT 25 JUNE 2019 NOT AVAILABLE
URL Results Available Results Summary Result Posting Date First Journal Publication Date
NOT AVAILABLE No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information