The aim of this study is to determine the effects of balance training exercises for improving static and dynamic balance on the deaf population
Design
double blinding, randomized control trial with parallel group design of 30 patients
Settings and conduct
The participants will be chosen from Special education school, Milat town Faisalabad. Double blinding in which participants and assessor both will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Congenitally Deaf children, Aged between 6 and 11 years, With profound hearing impairment, Without cochlear implantation, Ability to understand simple instructions, Ability to stand and walk independently.
exclusion criteria: Mental illness, Visual impairment, Cognitive impairment, Physical impairment, Neurological condition, Cardiovascular conditions
Intervention groups
The subjects will be divided into two groups randomly by chit and draw method: control group and training group. Group A will be training group (n=15) followed the balance training exercises for 4 weeks and group B will be control group (n=15) carried out its daily activities normally as usual.
Main outcome variables
our primary outcome will be to maintain the balance of subjects as much as they can do by performing exercises.
General information
Reason for update
Acronym
EBTEISDBDP
IRCT registration information
IRCT registration number:IRCT20200625047922N1
Registration date:2020-12-26, 1399/10/06
Registration timing:retrospective
Last update:2020-12-26, 1399/10/06
Update count:0
Registration date
2020-12-26, 1399/10/06
Registrant information
Name
Aimen Ghulam Rasool
Name of organization / entity
The university of Faisalabad
Country
Pakistan
Phone
+92 41 2693605
Email address
aimenmalik760@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-21, 1399/04/31
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Balance Training exercises for Improving Static and Dynamic Balance in Deaf Population
Public title
Balance Training exercises for Improving Static and Dynamic Balance in Deaf Population
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Congenitally Deaf children
Age between 6 and 11 years
With profound hearing impairment
Without cochlear implantation
Ability to understand simple instructions
Ability to stand and walk independently.
Exclusion criteria:
Mental illness
Visual impairmen
Cognitive impairment
Physical impairment
Neurological condition
Cardiovascular conditions.
Use of any assistive device
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
for screening the population convenient sampling will be choosen. Subjects will be randomly allocated to the Experimental and Control Group by using Chit and Draw method Simple Randomization. Group A will be experimental group and group b will be control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In our research, the participants and outcome assessors are blinded. As we wanted to make sure that no biassness at any level.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of THE UNIVERSITY OF FAISALABAD SARGODHA ROAD, FAISALABAD- PAKISTAN
Street address
Sargodha Road, University Town, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Approval date
2020-02-13, 1398/11/24
Ethics committee reference number
TUF/DR/DPT/085
Health conditions studied
1
Description of health condition studied
Static and dynamic balance training on deaf population
ICD-10 code
H91.93
ICD-10 code description
Unspecified hearing loss, bilateral
Primary outcomes
1
Description
Balance
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Berg Balance scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: interventional group will follow balance training exercises for 4 weeks in which 5sets/20 reps/All exercises to be held for 30 sec before returning to starting position that includes Static exercise:1. Stand on toes, feet apart.2. Stand on toes, feet together. 3. Stand on right foot unsupported, with left foot behind right knee. 4. Stand on left foot unsupported, with right foot behind left knee. 5. Stand with right heel touching left toe, feet in a straight line Dynamic exercise:1. Active warm up 2. Trunk twists 3. Walking lunges
Category
Rehabilitation
2
Description
Control group: control group perform their activity of daily living only.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Education School Milat town, Faisalabad
Full name of responsible person
Dr. Nimra Arshad ;PT
Street address
Milat Town, Faisalabad, Punjab 38000
City
Faisalabad
Postal code
38000
Phone
+92 41 9220363
Email
akhtarnusreen014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University Of Faisalabad
Full name of responsible person
Dr. Nimra Arshad ;PT
Street address
Sargodha Road, University Town, Faisalabad, Punjab 38000
City
Faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
nimra.arshad@tuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University Of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aimen Ghulam Rasool
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no 605/A block Kashmir Road Ghulam Muhammad Abad Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
041-693605
Email
aimenmalik760@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aimen Ghulam Rasool
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no 605/A block Kashmir Road Ghulam Muhammad Abad Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2693605
Email
aimenmalik760@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University Of Faisalabad
Full name of responsible person
Aimen Ghulam Rasool
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no 605/A block Kashmir Road Ghulam Muhammad Abad Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2693605
Email
aimenmalik760@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available