Objectives: whole body vibration is a new treatment in children with cerebral palsy that impact on spasticity and range of motion is still investigating. This project aim is examine the effectiveness of stretching exercises with vibration training on active and passive range of motion in the lower extremity joints in children with cerebral palsy.
Design: This study is a randomized trial stage two or three.
Participants: 12 children with spastic cerebral palsy 4 to 14 years.
Intervention: The intervention will be done in the spring and summer 95. In the control group 6 children with cerebral palsy will receive stretching exercises three times a week for 6 weeks. In the intervention group in additional stretching exercise they will receive whole body vibration 9 minutes three times a week for 6 week. Before the intervention and after 6 weeks of treatment, primary and secondary assessment, including: the severity of spasticity, fine motor skills and gross motor skills and manual 6-minute walk test and active and passive lower extremity range of motion will be done.
The main outcome variables: flexion and abduction of the hip, knee flexion, dorsiflexion and Plantar flexion in ankle, spasticity and 6-minute walking test
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040521686N2
Registration date:2016-06-11, 1395/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-11, 1395/03/22
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
2016-04-20, 1395/02/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of stretching exercises with whole body vibration on range of motion of lower extremity in spastic cerebral palsy children 4 to14 years
Public title
Effectiveness of stretching exercises with whole body vibration on range of motion of lower extremity in spastic cerebral palsy children 4 to14 years
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: The medical diagnosis of cerebral palsy children; Having aged 4 to 14 years; The ability to walk without falling for 6 minutes with or without assistive device; T the ability to execute commands 5.Being in the GMFCS 3, 2 and 1.
Exclusion criteria being: Any severe or progressive disease with cerebral palsy; children with fixed musculoskeletal deformity in the lower extremity; lower extremity surgery in the last 6 months; children with untreated fractures and uncontroled seizure; treatment by a botulinum toxin injection in the last three months; the limitations in range of motion in the knee more than 10 degrees
Age
From 4 years old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Ethics Committee
Street address
No.47,Semnan university of medical sciences, Basij Blvd, Semnan, Iran
Intervention group: stretching exercise for hamstring, Iliopesoas, cuff and adductor muscles along with whole body vibration for three sets of three-minute with break every three minutes three times a week for 6 weeks
Category
Other
2
Description
Control group: stretching exercise for hamstring, Iliopesoas, cuff and adductor muscles along with standing on off whole body vibration for three sets of three-minute with break every three minutes three times a week for 6 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neruromuscular 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
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidipour
Street address
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
Vice chancellor for research, 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 of siences / Faculty member
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Rehabiliation depatement, Km 5 Semnan to Damghan road, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ahmadizade.z@gmail.com
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 of sciences
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Rehabiliation depatement, Km 5 Semnan to Damghan road, Semnan, Iran
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 of sciences
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Rehabiliation depatement, Km 5 Semnan to Damghan road, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ahmadizade.z@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)