The purpose is to compare the effectiveness of Telepractice and in person sessions in children with cleft palate.
Design
Two arm parallel group randomised trial, Double-Blinded Trial, Simple randomized, Phase 1 on 50 patients. Randomization is done in a simple Randomization through lottery.
Settings and conduct
50 children aged 4-12 with cleft palate are divided into two groups.The intervention group received Articulation therapy via Telepractice in ZOOM platform for 10 45minutes sessions .The control group received Articulation therapy in 10 in person sessions.Articulation therapy includes routine Articulation approaches.Before and after treatment, 20minutes of spontaneous speech samples are recorded from each child.The (intelligibility) and (Production of consonants) in the CAPS form are scored.The level of mothers' satisfaction is measured using a 5-level Likert survey form. Numbers are measured and compared by Spss tool. Participants, analysts are blinded to the information of this research.
Participants/Inclusion and exclusion criteria
Unilateral, complete primary and secondary cleft palate
2. Absence of fistula after surgery
3. Absence of genetic or neurological syndromes
4. Calendar age of 4 to 12 years
5. Failure to identify severe language disorders
6. Presence of VPI after palate surgery
7. Presence of compensatory articulation errors with VPI through articulation evaluation tests
8. Normal hearing, recently evaluated by pure tone audiometry
Intervention groups
The main intervention group: Articulation therapy to correct compensatory Articulation errors is done via Telepractice.
Control group: for this group, Articulation therapy is done in the form of in person sessions to correct compensatory Articulation errors.
Main outcome variables
speech intelligibility
The percentage of correct consonants produced
The level of mother's satisfaction with Articulation therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221031056353N1
Registration date:2022-11-15, 1401/08/24
Registration timing:prospective
Last update:2022-11-15, 1401/08/24
Update count:0
Registration date
2022-11-15, 1401/08/24
Registrant information
Name
ayda abdi dezfuli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 6881
Email address
abdi.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of effectiveness of Articulation therapy for 4-12 years old children with cleft palate via Telepractice and in person sessions.
Public title
Investigation of effectiveness of Articulation therapy for 4-12 years old children with cleft palate via Telepractice and in person sessions.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral, complete primary and secondary cleft palate
Absence of fistula after surgery
Normal hearing, recently evaluated by pure tone audiometry
Calendar age of 4 to 12 years
Absence of middle ear infection
Presence of VPI after palate surgery
Presence of compensatory Articulation errors with VPI through Articulation evaluation tests
Exclusion criteria:
genetic or neurological syndromes
identify severe language disorders
Age
From 4 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done in the form of a lottery, so that the name of each participant is written on the same size and similar papers. The names are placed in a container. After that, the names are placed in two groups in order of coming out. One person enters the intervention group and one person enters the control group (odds receive Telepractice and evens receive face-to-face treatment) respectively.
Randomization is done by a person who is not involved in the research process.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants will not know whether the received technique is the main intervention or the routine intervention.
The data analyzer analyzes the Spss file and does not meet the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 27, 23th Ave, Kian Abad Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6155764137
Approval date
2022-10-22, 1401/07/30
Ethics committee reference number
IR.AJUMS.REC.1401.329
Health conditions studied
1
Description of health condition studied
cleft palate
ICD-10 code
Q35
ICD-10 code description
Cleft palate
Primary outcomes
1
Description
intelligibility of speech
Timepoint
Before treatment - After treatment
Method of measurement
5-level grading of speech intelligibility based on the CAPS form (0 = normal clarity and 4 = completely unnatural and unclear)
2
Description
The percentage of correct consonants produced
Timepoint
Before treatment - After treatment
Method of measurement
Dividing the correct produced consonants by the total produced consonants based on the speech sample
3
Description
The level of mother's satisfaction with Articulation therapy
Timepoint
Before treatment - After treatment
Method of measurement
Based on a 5-point Likert scale by asking the question: Were you satisfied with the treatment of your child?
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Articulation therapy for 25 children with cleft palate is carried out via Telepractice in 10 45-minutes sessions.
Category
Behavior
2
Description
Control group: Articulation therapy for 25 children with cleft palate is carried out in 10 in person 45-minutes sessions.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
cleft lip and cleft palate center of Ahvaz
Full name of responsible person
Ayda Abdi dezfuli
Street address
PArastar St., Pasdaran Blvd., Zeitoun Karmandi Town
City
Ahvaz
Province
Khouzestan
Postal code
3111111112
Phone
+98 903 511 6786
Email
Abdi.a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin moradi
Street address
Ostadan residential houses., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
91111111119
Phone
+98 916 631 2518
Email
neginmoradist@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ayda Abdi Dezfuli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No 27., 23th Ave., Kianabad Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6155764137
Phone
+98 61 3338 6881
Email
Abdi.a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Moradi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Ostadan Area., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
9111111119
Phone
+98 916 506 0146
Email
neginmoradist@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ayda Abdi Dezfuli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No 27., 23th., Kianabad Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6155764137
Phone
+98 61 3338 6881
Email
Abdi.a@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD