The self-care education and stabilizing exercise in pain, disability and muscle activities in mothers with chronic low back pain having children with cerebral palsy
This study aims to evaluate the effectiveness of self-care education and stabilizing exercise on pain, disability and muscle activity in mothers with chronic low back having children with cerebral palsy, for this purpose the mothers with chronic low back pain having children with cerebral palsy divided into two groups of experimental group and control group. In control group mothers will be received self-care education for 8 weeks, and in experimental group mothers in additional the self-care education they will be received stabilizing exercise for 8 weeks 3 times a week, the first assessment will be done before the intervention and secondary assessment will be done after the intervention and then 4 weeks after the end of interventions the assessment will be done in order to follow up the effects of the interventions
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041121686N1
Registration date:2015-06-25, 1394/04/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-25, 1394/04/04
Registrant information
Name
Zahra Ahmadizadeh
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
ahmadizadeh.z@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2015-06-20, 1394/03/30
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The self-care education and stabilizing exercise in pain, disability and muscle activities in mothers with chronic low back pain having children with cerebral palsy
Public title
The self-care education and stabilizing exercise in pain, disability and muscle activities in mothers with chronic low back pain having children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having a child with cerebral palsy; mother was the primary caregiver for children with cerebral palsy; having low back pain for at least three months
Exclusion criteria: a history of trauma in low back; reported the history of vertebral column fractures and hip fractures; report any neurological diseases such as multiple sclerosis, Parkinson's, etc.; report systemic diseases such as diabetes or Rheumatoid arthritis, tuberculosis, etc.; scoliosis and kyphosis of vertebral column and report any signs of serious disease in spinal included: Non-mechanical pain (without regard to time or activity); chest pain, wide paresthesia in the limbs, severe muscle weakness in lower limb, unexplained weight loss, fever, history of recently surgery, previous history of carcinoma, reported human immunodeficiency virus infection and substance abuse
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Km 5 Semnan to Damghan Road, Semnan
City
Semnan
Postal code
Approval date
2015-05-19, 1394/02/29
Ethics committee reference number
ir.semums.rec.1394.12
Health conditions studied
1
Description of health condition studied
Women with chronic low back pain having children with cerebral palsy
ICD-10 code
M70.8, M70
ICD-10 code description
Other soft tissue disorders related to use, overuse and pressure, Unspecified soft tissue disorder related to use, overuse and pressure, Low back pain
Primary outcomes
1
Description
Muscle activities
Timepoint
Before intervention, after 8 weeks intervention and 4 weeks after the end of intervention
Method of measurement
Ultrasonography
2
Description
Disability
Timepoint
Before intervention, after 8 weeks intervention and 4 weeks after the end of intervention
Method of measurement
Roland-Morris Questionnaire
3
Description
Pain
Timepoint
Before intervention, after 8 weeks intervention and 4 weeks after the end of intervention
Method of measurement
Visual Analogue Scale for pain
Secondary outcomes
1
Description
Depression
Timepoint
Before intervention, after 8 weeks intervention and 4 weeks after the end of intervention
Method of measurement
Beck depression questionnaire
Intervention groups
1
Description
Control group: the self-care education will be trained and the mothers will be received the booklet
Category
N/A
2
Description
Experimental group: in addition to self-care education they will be received muscle stabilization training for 8 week 3 times per week
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Zahra Ahmadizadeh
Street address
No.24, Neuromuscular Rehabilitation Research Center, Ghods Blvd, Mashahir square, Semnan, Iran
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology of Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidy pour
Street address
deputy of research and technology of Semnan university of medical sciences, No.47,Semnan university of medical sciences, Basij Blvd, Semnan, Iran
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology of Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Zahra Ahmadizadeh
Position
Master degree/ Faculty member
Other areas of specialty/work
Street address
school of Rehabilitation, Semnan University of Medical Sciences, Km 5 Semnan to Damghan Road, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ahmadizadeh.z@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Zahra Ahmadizadeh
Position
Master degree
Other areas of specialty/work
Street address
School of rehabilitation, Semnan University of Medical Sciences, Km 5 Semnan to Damghan Road
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
Ahmadizade.z@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Zahra Ahmadizadeh
Position
Master degree/ Lecturer
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Km 5 Semnan to Damghan Road, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
+98 23 3365 4180
Email
Ahmadizade.z@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)