Protocol summary

Study aim
The present study is designed to investigate the effect of teaching the family how to use handling techniques on their empowerment and also the functional mobility of the child.
Design
A clinical trial with a control group and an intervention group in parallel, which is randomized in a single-blind and stratified method. The study has one phase and the sample size of each group is 23 people.
Settings and conduct
The place of conducting the study is Tavanyab NGO and the method of conducting the study was explained in detail. The primary evaluator is subjected to the blinding process as a blind strain.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The child has been diagnosed with spastic cerebral palsy by a neurologist; The child does not have vision problems; The child's family does not intend to perform any surgery during the implementation of interventions; The mother of the child can be present as a parent of the participant in the study; The mother (participant's parent) must be fluent in Persian and able to read.
Intervention groups
Control group: The members of this group receive common occupational therapy interventions. The duration of providing common occupational therapy interventions commonly between the intervention and control groups will be 2 months (2 sessions per week and 45 minutes per session). Intervention group: The members of this group, while receiving common occupational therapy interventions, they also benefit from 5 related workshop sessions in case of increasing family awareness of their child's condition and training appropriate techniques for handling and positioning him.
Main outcome variables
Family empowerment; Gross motor function; Functional mobility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220630055330N1
Registration date: 2022-10-25, 1401/08/03
Registration timing: retrospective

Last update: 2022-10-25, 1401/08/03
Update count: 0
Registration date
2022-10-25, 1401/08/03
Registrant information
Name
Pooya Reaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4442 3675
Email address
reaei.po@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of group-based education of handling skills for parents with children with cerebral palsy on family empowerment and child’s functional mobility
Public title
The effects of group-based education of handling skills for parents with children with cerebral palsy on family empowerment and child’s functional mobility
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The child has been diagnosed with spastic cerebral palsy by a neurologist The child does not have vision problems The child's family does not intend to perform any surgery during the implementation of interventions The mother of the child can be present as a parent of the participant in the study The mother (participant's parent) must be fluent in Persian and able to read
Exclusion criteria:
The age of the child is less than 3 years or more than 10 years.
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
We plan to divide people based on the score of the GMFCS questionnaire into three categories with scores 1 and 2, with score 3 and with scores 4 and 5, and then to perform randomization in a way to select a number of samples from each of these categories almost equally in the intervention and control groups. First, by drawing a two-by-two table, we specify all the placement situations of the samples in the final groups: 1) intervention/control 2) control/intervention 3) intervention/intervention/control/control. Then, by lottery, one of these arrangement methods is selected and we exceed to the next step. In the next step, the ID of all the samples in the form of a code along with their GMFCS questionnaire scores are written on separate sheets and arranged randomly. Then in three envelopes (based on the scores of the GMFCS questionnaire, which had three categories with scores 1 and 2, with score 3 and with scores 4 and 5), on the sheets of the sorting system that was determined earlier (for example, intervention/intervention/control/control) In the same way, it is written separately and repetitively and placed inside triple envelopes. Then the sheets related to the ID of the samples (which apart from their ID code, also includes their GMFCS score) are revealed in order, and based on their GMFCS scores, we go to the desired envelope and take out the sorted sheets from inside it. Based on the writing on the pages inside the envelope (intervention or control), the target sample is randomly placed in one of the intervention or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator will not know which group each sample belongs to in all stages of the evaluation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Unit 3, No. 3, 3rd Piroozi Alley, Nikzare Ave., 22nd Bahman Ave., Ashrafi Esfahani Blvd., Bagh Feiz
City
Tehran
Province
Tehran
Postal code
1473178434
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.IUMS.REC.1401.246

Health conditions studied

1

Description of health condition studied
Cerebral Palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy

Primary outcomes

1

Description
Family empowerment score in the Family Empowerment Scale
Timepoint
Measuring family empowerment score for the first time at the beginning of the study, for the second time one month after the start of the study, for the third time two months after the start of the study (at the end of the interventions), for the fourth time one month after the end of the interventions and for the fifth time two months after the end of the Interventions
Method of measurement
Family Empowerment Scale

2

Description
Gross motor function score in the Gross Motor Function Measurement
Timepoint
Measuring Gross motor function score for the first time at the beginning of the study, for the second time one month after the start of the study, for the third time two months after the start of the study (at the end of the interventions), for the fourth time one month after the end of the interventions and for the fifth time two months after the end of the Interventions
Method of measurement
Gross Motor Function Measurement - 88

3

Description
Functional mobility score in the Mobility subscale of the Pediatric Evaluation of Disability Inventory
Timepoint
Measuring Functional mobility score for the first time at the beginning of the study, for the second time one month after the start of the study, for the third time two months after the start of the study (at the end of the interventions), for the fourth time one month after the end of the interventions and for the fifth time two months after the end of the Interventions
Method of measurement
Mobility subscale of the Pediatric Evaluation of Disability Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The members of this group, while receiving common occupational therapy interventions including active and passive stretching exercises to improve range of motion and adjust muscle tone, facilitate gross and fine movement patterns in the form of developmental patterns and facilitate the child's movement functions with purposeful activities, they also benefit from 5 related workshop sessions in case of increasing family awareness of their child's condition and training appropriate techniques for handling and positioning him, the content of which is described in detail below. The first group session: During this one-hour session, the researcher will provide information on the nature of cerebral palsy, its causes, types and symptoms of each, functional levels, prognosis and related disorders, in addition to the introduction of drugs used to reduce spasticity and control convulsions and occupational therapy common interventions, through PowerPoint. The second group session: In this session, the researcher guides the parents to discuss and exchange opinions about the handling problems of their children, their musculoskeletal pain, the decrease in the quality of life of parents due to the child's illness, the decrease in the quality of the parent's health, the disruption of their occupational balance and related topics. The third group session: this session will be about children's functional problems in general; In this way, first the researcher explains the areas of occupational performance in the form of PowerPoint, and then parents are invited to express their challenges and the child's challenges in the introduced areas. 4th and 5th group session: By analyzing the discussions of the previous three group sessions that have been explained up to this point, the researcher has identified the basic problems that families are facing and prepares interventions for group training to parents in the form of PowerPoint, which will be presented in the fourth and fifth group sessions. It should be noted that there will be a suitable platform for discussion and exchange of parent's opinions, just like the previous group sessions.
Category
Rehabilitation

2

Description
Control group: The members of this group receive common occupational therapy interventions, including active and passive stretching exercises to improve the range of motion and adjust muscle tone, facilitate gross and fine movement patterns in the form of developmental patterns, and facilitate the child's movement functions with purposeful and appropriate activities. The duration of providing common occupational therapy interventions commonly between the intervention and control groups will be 2 months (2 sessions per week and 45 minutes per session).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tavanyab Association
Full name of responsible person
Khosrow Mansourian
Street address
No. 2, Martyr Jafarzadegan Alley, North Kargar Ave., Enqelab Sq.
City
Tehran
Province
Tehran
Postal code
1418815665
Phone
+98 21 6693 5533
Fax
+98 21 6693 5124
Email
anjoman.ehya1@gmail.com
Web page address
https://www.tavanyabngo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Iran University of Medical Science, next to Milad tower, Hemmat Expressway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir
Web page address
https://www.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Pooya Reaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Unit 3, No. 3, 3rd Piroozi Alley, Nikzare Ave., 22nd Bahman Ave., Ashrafi Esfahani Blvd., Bagh Feiz
City
Tehran
Province
Tehran
Postal code
1473178434
Phone
+98 21 4442 3675
Email
pooya369@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malek Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation Science, Madadkaran St., Shahid Shah Nazari St., Mother Square, Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
amini.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pooya Reaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Unit 3, No. 3, 3rd Piroozi Alley, Nikzare Ave., 22nd Bahman Ave., Ashrafi Esfahani Blvd., Bagh Feiz
City
Tehran
Province
Tehran
Postal code
1473178434
Phone
+98 21 4442 3675
Email
pooya369@yahoo.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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