Protocol summary
-
Study aim
-
Developing a protocol of “swallowing therapy with action observation treatment” and investigating its effectiveness on swallowing and feeding in 3 to 12 years old children with spastic cerebral palsy
-
Design
-
This is a concealed randomized preliminary clinical trial phase 2 with two parallel group design of 20 children. Participants and Researchers will be blinded to the allocation.
-
Settings and conduct
-
This study will be conducted in Semnan city. If children are eligible through an online assessment, their care giver will sign a consent form and enter the study. Participants will be randomly assigned to the intervention and placebo groups by an independent researcher. In the first meeting, an assessor will evaluates each child and then a therapist will hold a therapy session for each child based on their assignment and will teach the program to their caregivers and give a training brochure to them do the therapy at home twice a day, 5 days a week for 10 weeks. Children will be assessed at the beginning of the study, 10 weeks later and 1 and 3 months after the intervention.
-
Participants/Inclusion and exclusion criteria
-
Participants are 3 to12 years old children with spastic cerebral palsy who have oral phase problems of swallowing, with no sever hearing or visual problems and intellectual disability and uncontrolled seizure and progressive neurological disease. Children should not be tube fed and their caregivers should be literate and having access to internet and a smart phone or computer.
-
Intervention groups
-
The experimental group will receive action observation therapy (AOT) which is watching each target movements before doing that, and then will imitate that movement during functional oral sensory-motor therapy (F-OST).
The placebo group will receive the same protocol but instead of AOT will watch movies not related to target oral movements.
-
Main outcome variables
-
Swallowing function
General information
-
Reason for update
-
Postponing sampling time
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210629051738N1
Registration date:
2021-09-10, 1400/06/19
Registration timing:
prospective
Last update:
2021-11-10, 1400/08/19
Update count:
1
-
Registration date
-
2021-09-10, 1400/06/19
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-11-10, 1400/08/19
-
Expected recruitment end date
-
2021-12-10, 1400/09/19
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Developing a protocol of “swallowing therapy with action observation treatment” and investigating its effectiveness on swallowing and feeding in 3 to 12 years old children with spastic cerebral palsy
-
Public title
-
The effect of “swallowing therapy with action observation treatment” protocol
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Spastic cerebral palsy
3-12 years old
Having problem in oral phase of dysphagia
Literate caregiver
Having access to internet and smart phone or computer
Exclusion criteria:
progressive neurological disease
severe visual problems
severe hearing problems
intellectual disorder
orofacial syndromes
uncontrol seizure
Tube feeding
-
Age
-
From 3 years old to 12 years old
-
Gender
-
Both
-
Phase
-
2-3
-
Groups that have been masked
-
- Participant
- Outcome assessor
-
Sample size
-
Target sample size:
20
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Participants will be assigned to one of the two experimental and control groups using blocked randomization method with randomly selected block sizes of 4 and 6. Randomization will be done by an independent researcher from a different research center using an internet softwires so the participants and the assessor will be concealed for assignment.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Participants will not know if they are in the experimental or control groups. As this a parental based program so participants do not need to come to clinic a lot and they are connected to therapists during the mostly through internet during the intervention and kept separated from each other.
The evaluator is also different from the therapist and will not be given information about interventions and the individuals` assignment.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-08-25, 1400/06/03
-
Ethics committee reference number
-
IR.USWR.REC.1400.122
Health conditions studied
1
-
Description of health condition studied
-
cerebral palsy
-
ICD-10 code
-
G80
-
ICD-10 code description
-
Cerebral palsy
2
-
Description of health condition studied
-
dysphagia
-
ICD-10 code
-
R13.1
-
ICD-10 code description
-
Dysphagia
Primary outcomes
1
-
Description
-
Swallowing function
-
Timepoint
-
Pre and post intervention, 1 and 3 months after the intervention as follow up asessment
-
Method of measurement
-
Oral Motor Assessment Scale (OMAS), Schedule Oral Motor Assessment (SOMA), Dysphagia Disorder Survey (DDS)
Secondary outcomes
1
-
Description
-
feeding performance
-
Timepoint
-
Before and after therapy, 1 and 3 months after the intervention as follow up assessment
-
Method of measurement
-
Pedi-Eat scale
2
-
Description
-
Caregivers` quality of life
-
Timepoint
-
Before and after therapy, 1 and 3 months after the intervention as follow up assessment
-
Method of measurement
-
Feeding swallowing impact survey
Intervention groups
1
-
Description
-
Intervention group: Intervention includes action observation treatment (AOT) and functional oral sensorimotor therapy (F-OST). First each target movements performing by a healthy child in a video will be observed by the participant as (AOT) and then will be practiced as F-OST. Intervention will last for 10 weeks, 5 days a week, 2 times a day and 20 minutes each time.
-
Category
-
Rehabilitation
2
-
Description
-
Control group: Like the intervention group, the intervention includes functional oral sensorineural therapy (F-OST), but instead of AOT, a placebo will be used, i.e. the person will spend the same time watching the video, but the videos are not related to the target movements. The treatment will last for 10 weeks, 5 days a week, 2 times a day for 20 minutes each time.
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
University of social welfare and rehabilitation 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is 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
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is 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
-
Title and more details about the data/document
-
Data collected for the primary outcome measures are to be shared.
-
When the data will become available and for how long
-
6 months after publication
-
To whom data/document is available
-
It's only available for people working in academic institutions.
-
Under which criteria data/document could be used
-
Requests for sharing data should be sent to the person responsible for general inquiries.
-
From where data/document is obtainable
-
Requests for sharing data should be sent to the person responsible for scientific inquiries. Maryam Mokhlesin
m_mokhlessin@yahoo.com
-
What processes are involved for a request to access data/document
-
Data will be shared after receiving requests by email in less than 1 month.
-
Comments
-