Comparison of the effects of maternal handling training on occupational performance of children with cerebral palsy and family caregiving satisfaction in Arak city.
Abstract:
The aim of this study is the comparison of the effects of maternal handling training on occupational performance of children with cerebral palsy (CP) and family caregiving satisfaction in Arak city. This research is an experimental, clinical trial study; fifty children with CP (4-12 years old) in the levels of III-IV Gross Motor Function Measure Expanded & Revised (GMFM E&R) recruit based on convincing sampling method and divided randomly into two groups of intervention and control. The caregivers in intervention group determine maternal handling training priorities and receive specific educations in this regards by an occupational therapist. In the first pre-test, Intervention & control group receive routine occupational therapy interventions for 4 weeks. After that, caregivers of the intervention group, perform maternal handling training interventions based on detecting priorities for children with CP for three months. A demographic information questionnaire and Canadian Occupational Performance Measure (COPM) use to collect data. Then, data, analyze in three phases; pretest, before interventions and after interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031521478N1
Registration date:2015-07-10, 1394/04/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-10, 1394/04/19
Registrant information
Name
Hamid Dalvand
Name of organization / entity
Arakk University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6090
Email address
h.dalvand@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of maternal handling training on occupational performance of children with cerebral palsy and family caregiving satisfaction in Arak city.
Public title
Maternal handling training
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:children with cerebral palsy (CP) be diagnose by pediatric neurologist ; children with CP aged between 4-12 years old ; children with CP in levels of III-V Gross Motor Function Classification System Expanded &Revised (GMFCS E&R).
Exclusion criteria: CP children with refractory seizure ; CP children with Muscular – skeleton surgery.
Age
From 4 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
School of Rehabilitation, Medical science building number 2; Golestan town, Mostafakhomeini Street.
City
Arak
Postal code
381-869-3395
Approval date
2015-05-02, 1394/02/12
Ethics committee reference number
93-176-31
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
Occupational Performance of children with CP & Caregiver Satisfaction
Timepoint
Data gather in three phases; pre-test (4 weeks before intervention), before interventions and 3 month after interventions.
Method of measurement
Occupational Performance of children with CP and Caregiver Satisfaction (both) measure with Canadian Occupational Performance Measure (COPM)
Secondary outcomes
1
Description
Maternal Handling Training
Timepoint
Before and 3 months after intervention
Method of measurement
Canadian Occupational Performance Measure (COPM)
Intervention groups
1
Description
Interventions; for intervention group perform in four phases; pretest, before intervention, intervention and after intervention.
Pretest phase: Intervention group receive routine occupational therapy interventions for 4 weeks. Occupational performance for children with CP and level of satisfaction for caregivers assess with COPM. This period is for determine the effectiveness of routine occupational therapy without maternal handling therapy.
Before intervention phase: Again, we use COPM for identifying of maternal handling training priorities, occupational performance for children with CP and level of satisfaction for caregivers for intervening group.
Intervention phase: A 2-hour maternal handling training workshop held for caregivers of the intervention group based on identifying priorities in COPM. During this session, caregivers acquaint with educations for special care of children with CP. After that, a hand book entitled "knowing more about our children and acting better" and video CD in this regard gifts to the caregivers for studying. , Moreover, Over the 3-month period of intervention, intervention group kept on their routine occupational therapy interventions.
After intervention phase: Differences between occupational performance for children with CP and level of satisfaction for caregivers assess with COPM after 3 month intervention.
Category
Treatment - Other
2
Description
Interventions; for control group perform in four phases; pretest, before intervention, intervention and after intervention.
Pretest phase: Control group receive routine occupational therapy interventions for 4 weeks. This period is for determine the effectiveness of routine occupational therapy without maternal handling therapy. Occupational performance for children with CP and level of satisfaction for caregivers assess with COPM.
Before intervention phase: Again, we use COPM for identifying of maternal handling training priorities, occupational performance for children with CP and level of satisfaction for caregivers for control group.
Intervention phase: During three month intervention, control group do not receive maternal handling training, but they kept on their routine occupational therapy interventions.
After intervention phase: Differences between occupational performance for children with CP and level of satisfaction for caregivers assess with COPM after 3 month intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation
Full name of responsible person
Dr. Hamid Dalvand
Street address
School of Rehabilitation, Medical science building number 2; Golestan town, Mostafakhomeini Street
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- chancellor of Research and Technology, Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafeie
Street address
School of Medicine, Medical science building number 2; Golestan town, Mostafakhomeini Street
City
Arak
Grant name
Grant code / Reference number
93/176/13
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- chancellor of Research and Technology, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Hamid Dalvand
Position
PhD of Occupational Therapy / Assisstant Professor
Other areas of specialty/work
Street address
School of Rehabilitation, Medical science building number 2; Golestan town, Mostafakhomeini Street
City
Arak
Postal code
381-869-3395
Phone
+98 86 3313 6090
Fax
Email
hamiddalvand@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Hamid Dalvand
Position
PhD of Occupational Therapy / Assisstant professor
Other areas of specialty/work
Street address
School of Rehabilitation, Medical science building number 2; Golestan town, Mostafakhomeini Street
City
Arak
Postal code
381-869-3395
Phone
+98 86 3313 6090
Fax
Email
hamiddalvand@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Hamid Dalvand
Position
PhD of Occupational Therapy / Assisstant professor
Other areas of specialty/work
Street address
School of Rehabilitation, Medical science building number 2; Golestan town, Mostafakhomeini Street.
City
Arak
Postal code
381-869-3395
Phone
+98 86 3313 5824
Fax
Email
hamiddalvand@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)