To compare the effects of single-session auditory versus visual feedback on balance in hemiplegic Cerebral Palsy.
Design
Two parallel groups randomized control trial with assessor-blinded
Settings and conduct
The assessor will have no knowledge of the type of intervention and will employ a pre-test/post-test design immediately following a single session for the same patients: first receiving conventional therapy plus visual or auditory feedback and after 48 hours as washing time they will receive conventional therapy plus auditory or visual feedback depend to the sampling result.
Participants/Inclusion and exclusion criteria
Inclusion
1. Aged between 6 years to 12 years;
2. Diagnosis of hemiplegic spastic CP,
3. Grade of 1 & 2 on the Modified Ashworth Scale (MAS)
4. Level I & II (able to walk without limitations) of the Gross Motor Function Classification System according to child’s age,
5. No uncorrected vision or hearing impairments;
6. Able to follow and accept the verbal instructions.
7. Able to stand without lower limbs brace.
Exclusion
The participants will exclude if they having:
8. Other neurological condition like hydrocephalus.
9. Having leg length and Muscles shortening.
10. Having pes cavus.
11. Having any recent fracture or any other condition that poses a threat to stability.
12. Having vestibular or Optical pathology.
Intervention groups
Conventional Balance Therapy by balance board + Visual Feedback or Auditory Feedback Then after 48 hours will receive Conventional Balance Therapy by balance board + Auditory Feedback or visual feedback based on the result of sampling.
Total treatment time will be Conventional Physical Therapy 30 mins + 10 mins of visual or auditory feedback training.
Main outcome variables
Modified Ashworth Scale
Pediatric Balance Scale (Berg Balance)
Timed One-Leg Stance test
Time Up and Go test (TUG)
Centre of Pressure (COP) displacement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059340N1
Registration date:2023-11-19, 1402/08/28
Registration timing:prospective
Last update:2023-11-19, 1402/08/28
Update count:0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
Ghaith Alhashimi
Name of organization / entity
Country
Iraq
Phone
+964 773 004 6618
Email address
ghaithfadhil89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2024-04-01, 1403/01/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of single session auditory versus visual feedback on balance in the children with Hemiplegic Spastic Cerebral Palsy
Public title
Effects of auditory and visual feedback on balance in the children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 6 years to 12 years;
Diagnosis of hemiplegic spastic CP,
Grade of 1 & 2 on the Modified Ashworth Scale (MAS) scoring from 0 = (No increase in tone) to 4 = (limb rigid in flexion or extension) in the ankle plantar flexors muscles and quadriceps muscles.
Level I & II (able to walk without limitations) of the Gross Motor Function Classification System according to child’s age, the levels range is (Level I: able to walk without limitations) to (Level V: transported in manual wheelchair).
No uncorrected vision or hearing impairments;
Able to follow and accept the verbal instructions.
Able to stand without lower limbs brace.
Exclusion criteria:
Other neurological conditions like hydrocephalus.
Having leg length and Muscles shortening.
Having pes cavus.
Having any recent fracture or any other condition that poses a threat to stability.
Having vestibular or Optical pathology.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will use a convenience sampling method with sample random for the participants who meet the inclusion criteria to determine which intervention the patient will receive in the beginning with consideration of the matching between the groups in terms of side effects of the body and age. The lottery method will be used for randomization to minimize bias.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will have no knowledge of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tehran University of Medical Sciences
Street address
No. 21, Dameshgh St., Vali-e Asr Ave., Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2023-11-18, 1402/08/27
Ethics committee reference number
IR.TUMS.FNM REC.1402.158
Health conditions studied
1
Description of health condition studied
Spastic Hemiplegic Cerebral palsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Spasicity
Timepoint
Before intervention and after finish the intervention immediately.
Method of measurement
The modified Ashworth scale.
2
Description
Balance ability
Timepoint
Before intervention and after finish the intervention immediately.
Method of measurement
Berg Balance scale
3
Description
Walking speed
Timepoint
Before intervention and after finish the intervention immediately.
Method of measurement
Time up and go test
4
Description
Balance Time
Timepoint
Before intervention and after finish the intervention immediately.
Method of measurement
One leg stands test
5
Description
Center of Pressure displacement
Timepoint
Before intervention and after finish the intervention immediately.
Method of measurement
Nintendo Wii Balance Board
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Conventional Balance Therapy by balance board Plus Visual Feedback.
Category
Rehabilitation
2
Description
Intervention group: Conventional Balance Therapy by balance board plus Auditory Feedback.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadr Alqanat Medical Rehabilitation Center
Full name of responsible person
Iemad Khudair AlQaisy
Street address
Sadr Alqanat Highway street
City
Alrsafa
Postal code
000000
Phone
+964 790 588 9127
Email
mbmhkh1989@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghaith Fadhil Lafta Alhashimi
Street address
No. 21, Dameshgh St., Vali-e Asr Ave., Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8889 6692
Email
ghaithfadhil89@gmail.com
Grant name
Ghaith Fadhil Lafta Alhashimi
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal Funding
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
IQ
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghaith Fadhil Lafta Alhashimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran University of Medical Sciences, Faculty of Rehabilitation, No. 336, corner of Safi Alishah St., Shemiran Lane, Tehran,
City
Tehran
Province
Tehran
Postal code
11155-1683
Phone
+98 904 436 7911
Email
ghaithfadhil89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran University of Medical Sciences, Faculty of Rehabilitation, No. 336, corner of Safi Alishah St., Shemiran Lane, Tehran.
City
Tehran
Province
Tehran
Postal code
11155-1683
Phone
+98 912 370 3379
Email
shadmehr@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghaith Fadhil Lafta Alhashimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran University of Medical Sciences, Faculty of Rehabilitation, No. 336, corner of Safi Alishah St., Shemiran Lane, Tehran.
City
Tehran
Province
Tehran
Postal code
11155-1683
Phone
+98 904 436 7911
Email
ghaithfadhil89@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