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Investigating the effect of hybrid telepractice and in-person speech therapy on speech characteristics in children with repaired cleft lip and palate

Protocol summary

Study aim
Determining the effect of hybrid telepractice and in person speech therapy on speech characteristics in children with cleft lip and palate
Design
It is a single subject study with an ABA design that includes three phases: 1. Phase A (baseline), 2. Phase B (intervention), and 3. Phase A (follow up). The number of samples based on similar studies is 4 people.
Settings and conduct
The study will be held in Kashani speech therapy clinic. It has 3 phases: baseline, intervention and follow-up, and each phase is compared with its adjacent phase. All individuals receive the intervention, and each individual is considered their own control.
Participants/Inclusion and exclusion criteria
Persian-speaking children aged 3 to 12 with cleft palate with or without cleft lip and with normal hearing who do not have language or cognitive disorders, genetic or neurological syndromes. have at least one type of compensatory articulation errors and do not have a palatal fistula in the placement of production of oral consonants and have the ability to cooperate in treatment sessions. Also, do not receive speech intervention when entering the study in other centers.
Intervention groups
In the base line phase without intervention, 3 data points are obtained during 3 weeks of perceptual assessment. In the intervention phase, 30 speech therapy sessions will be provided (3 in person and 2 telepractice sessions per week) using the phonetic phonological approach. and perceptual assessments are performed at 5 data points. During the follow-up phase, the process of perceptual assessment and recording of 3 data points similar to the base line phase will be done again.
Main outcome variables
hybrid telepractice and in-person speech therapy, percentage of correct consonants in word imitation, sentence imitation and word naming, percentage of Cleft speech type characteristics, percentage of stimulable consonants.

General information

Reason for update
Acronym
CP±L
IRCT registration information
IRCT registration number: IRCT20230403057804N3
Registration date: 2024-06-14, 1403/03/25
Registration timing: prospective

Last update: 2024-06-14, 1403/03/25
Update count: 0
Registration date
2024-06-14, 1403/03/25
Registrant information
Name
Kowsar Baghban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
baghban.kowsar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-15, 1403/03/26
Expected recruitment end date
2024-08-31, 1403/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of hybrid telepractice and in-person speech therapy on speech characteristics in children with repaired cleft lip and palate
Public title
Effectiveness of hybrid telepractice and in-person speech therapy on speech characteristics in children with cleft lip and palate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of cleft palate with or without cleft lip which is repaired. The age range is 3 to 12 years. Based on the informal assessments of the speech and language pathologist and the child's file in the cleft palate team, the language development is within the normal range and there are no cognitive impairments. Persian as the dominant language of the child. During the perceptual assessments of speech and language, have at least one type of 4 categories of non-oral characteristics (compensatory articulation error) with at least one error consonant. Do not receive speech therapy in other centers when entering the study, because it does not interfere with the treatment provided in the present study.
Exclusion criteria:
Based on the information in the file, do not have a known genetic or neurological syndrome associated with cleft palate such as pierre robin syndrome or velocardiofacial syndrome. Because it is important that the child under study does not have intellectual, cognitive and language disorders caused by these syndromes. After surgery, there should be no palatal fistula in the soft palate or hard palate. Because having a fistula in the placement of production of oral consonants causes an abnormal change in the contact placement of the tongue with the palate, even with the provision of treatment. The family should be willing to cooperate to receive intensive treatment. For any reason, the child cannot continue the study process or does not cooperate during the research.
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 4
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The study design is single-subject and assessment-intervention-assessment (ABA).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2024-06-09, 1403/03/20
Ethics committee reference number
IR.UMSHA.REC.1403.164

Health conditions studied

1

Description of health condition studied
The effect of hybrid telepractice and in person speech therapy on speech characteristics in children with cleft lip and palate
ICD-10 code
Q37
ICD-10 code description
Cleft palate with cleft lip

Primary outcomes

1

Description
Cleft speech type characteristics
Timepoint
Three data points before the intervention and in the baseline phase, five data points in the intervention phase and three data points in the follow-up phase after the intervention.
Method of measurement
Perceptual assessment and obtaining the percentage of occurrence of the variable

Secondary outcomes

1

Description
Percentage of correct consonants in word imitation
Timepoint
Three data points before the intervention and in the baseline phase, five data points in the intervention phase and three data points in the follow-up phase after the intervention.
Method of measurement
Perceptual assessment and obtaining the percentage of occurrence of the variable

2

Description
Percentage of correct consonants in word naming
Timepoint
Three data points before the intervention and in the baseline phase, five data points in the intervention phase and three data points in the follow-up phase after the intervention.
Method of measurement
Perceptual assessment and obtaining the percentage of occurrence of the variable

3

Description
Percentage of correct consonants in sentence imitation
Timepoint
Three data points before the intervention and in the baseline phase, five data points in the intervention phase and three data points in the follow-up phase after the intervention.
Method of measurement
Perceptual assessment and obtaining the percentage of occurrence of the variable

4

Description
Stimulable consonants
Timepoint
Three data points before the intervention and in the baseline phase, five data points in the intervention phase and three data points in the follow-up phase after the intervention.
Method of measurement
Perceptual assessment and obtaining the percentage of occurrence of the variable

Intervention groups

1

Description
Intervention group: Children with cleft palate with or without cleft lip / In the first phase (baseline) without intervention, 3 data points are obtained during 3 weeks of continuous speech perceptual assessments. In the intervention phase, 30 speech therapy sessions (3 in person sessions and 2 telepractice sessions per week) will be provided using the phonological phonetic approach, and perceptual assessments will be performed at 5 data points. During the follow-up phase, the process of perceptual assessment of the continuous speech sample and recording of 3 data points similar to the baseline phase will be done.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Speech therapy clinics in Hamadan University of Medical Sciences
Full name of responsible person
Kowsar Baghban
Street address
Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 1572
Email
baghban.kowsar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokoohi
Street address
5th floor, Headquarters of Hamadan University of Medical Sciences, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Kowsar Baghban
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Faculty of Rehabilitation, Hamedan University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1752
Email
baghban.kowsar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Kowsar Baghban
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Faculty of Rehabilitation, Hamedan University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1572
Email
baghban.kowsar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sogand Zarei
Position
Master of Science student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Faculty of Rehabilitation, Hamedan University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1572
Email
sogandzarei7827@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
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