Evaluation of the synergistic effect of vibration and Hinged AFO on gait, function and spasticity of gastrosoleus muscle after one month in children with spastic hemiplegic cerebral palsy.
Design
Study groups include two groups of intervention and control. The intervention group will receive articulated AFO with vibrators and the control group will receive articulated AFO without vibrators. Not randomized. Not blinded. The sample size includes 24 people, which will be equal to 12 people in each group.
Settings and conduct
Participants will be selected from children referring to clinics of school of rehabilitation sciences (Iran University of Medical Sciences). Test conditions will be explained. The volunteers, will sign the consent form. Demographic information will be completed; the necessary assessments will then be made
Participants/Inclusion and exclusion criteria
Children with spastic hemiplegic cerebral palsy between the ages of 4 and 12 will be included.
Intervention groups
The orthosis used in this study is a Hinged AFO, which It will be adjusted according to the participants' ability to control the knee joint in the direction of dorsiflexion. The movement of the plantar flexion in this orthosis will be completely limited. The control group will receive the orthosis, but the intervention group will receive the same orthosis in combination with five coin vibrators located on the gastrosoleus muscles. These vibrators will be turned on only during walking.
Main outcome variables
Step length; Step width; Walking speed; Cadence; Ankle joint kinematic; Knee joint kinematic; Hip joint kinematic; plantar flexor spasticity; Duration of a full walking cycle; Performance; Satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200915048725N2
Registration date:2021-08-01, 1400/05/10
Registration timing:registered_while_recruiting
Last update:2021-08-01, 1400/05/10
Update count:0
Registration date
2021-08-01, 1400/05/10
Registrant information
Name
Maryam Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
jalali.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2022-04-18, 1401/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Hinged AFOs with and without vibration on gait and daily function in children with spastic hemiplegic cerebral palsy
Public title
Comparison of the effect of Hinged AFOs with and without vibration on gait and function in children with spastic hemiplegic cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with spastic hemiplegic cerebral palsy aged 4 to 12 years
AFO prescribed by a medical specialist or therapist
GMFCS level I to III
The child is able to stand independently
At least 2 weeks have passed since the previous lower limb orthosis was received
At least six months have passed since the last Botox injection in the lower extremities
spasticity grade based on Ashworth scale (2 and 3)
Exclusion criteria:
Any injuries or wounds at the orthosis site
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:
24
Randomization (investigator's opinion)
Not 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
Ethics committee of Iran University of Medicine Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.IUMS.REC.1400.171
Health conditions studied
1
Description of health condition studied
Spastic hemiplegic cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
Ankle joint kinematic
Timepoint
Before the intervention and one month after
Method of measurement
Three-dimensional motion analysis
2
Description
Knee joint kinematic
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Three-dimensional motion analysis
3
Description
Hip joint kinematic
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Three-dimensional motion analysis
4
Description
Stride length
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Three-dimensional motion analysis
5
Description
Step width
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Three-dimensional motion analysis
6
Description
Function
Timepoint
Before the intervention and one month after the intervention and two weeks after weaning of the orthosis
Method of measurement
PEDI questionnaire
7
Description
ُSpeed of walking
Timepoint
Before the intervention and one month after the intervention
Method of measurement
120 / step length × cadence
8
Description
Cadence
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Number of steps per second
9
Description
Duration of a complete walking cycle
Timepoint
Before the intervention and one month after the intervention
Method of measurement
According to each participant's gait pattern, the initial contact is detected based on kinematic data and the time interval between two successive initial contacts will be measured.
10
Description
Spasticity of the gastrosoleus muscles
Timepoint
Before the intervention and one month after the intervention and two weeks after weaning the orthosis
Method of measurement
Ashworth Scale
11
Description
satisfaction
Timepoint
Before the intervention and one month after the intervention
Method of measurement
OPUS Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The orthosis designed for the intervention group is a hinged AFO. Based on the ability of each participant to control the knee joint, range of motion of the ankle joint in the direction of dorsiflexion will be adjusted. In fact, participants with a higher level of knee control will be able to more range of motion of dorsiflexion, and accordingly, participants who have less knee control will be able to less range of motion of the ankle . The joints are made of stainless steel with a weight of 100 grams. A joint pair will be used for each orthosis. Also, the body of the orthosis is made of polypropylene sheet with a thickness of four mm, which will be shaped based on the shape of each participant's foot. The orthosis trim line is from lower than head of fibula bony to the fingertips. It will then be connected to the participants' feet via four straps. A strap is located at the leg below the knee. One strap above the ankle and one strap below the ankle and the last strap will be on the toes. The total weight of the orthosis will be between 300 and 500 grams depending on the size of the participants' feet. This orthosis also has a vibrating system. The vibrating system consists of five 5 mm diameter Lee coil vibrators with a frequency of 60 Hz, which are located on the two muscles of gastrocnemius and soleus. The duration of treatment is one month. Participants wear orthoses for at least 8 hours each day. Vibration control will be via a floor switch so that the vibrators will be turned on by placing the heel on the ground. Due to the accurate recording of the amount of light and the number of times the vibrators are turned on, a data logger will be connected to the system to record the system data based on the duration of use during one month.
Category
Rehabilitation
2
Description
Control group: The orthosis designed for this group is a hinged AFO. Based on the ability of each participant to control the knee joint, range of motion of the ankle joint in the direction of dorsiflexion will be adjusted. In fact, participants with a higher level of knee control will be able to more range of motion of dorsiflexion, and accordingly, participants who have less knee control will be able to less range of motion of the ankle . The joints are made of stainless steel with a weight of 100 grams. A joint pair will be used for each orthosis. Also, the body of the orthosis is made of polypropylene sheet with a thickness of four mm, which will be shaped based on the shape of each participant's foot.The orthosis trim line is from lower than head of fibula bony to the fingertips. It will then be connected to the participants' feet via four straps. A strap is located at the leg below the knee. One strap above the ankle and one strap below the ankle and the last strap will be on the toes. The duration of treatment is one month. Participants wear orthoses for at least 8 hours each day. The orthosis does not have a vibrating system for this group of participants. The total weight of the orthosis will be between 300 and 500 grams depending on the size of the participants' feet.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Scienses, School of Rehabilitation Sciences, Orthotics and Prosthetics De
Full name of responsible person
Maryam Jalali
Street address
Madadkaran Ave., Shahnazari St., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 0947
Email
jalali.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Web page address
https://vcr.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
Maryam Jalali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Madadkaran Ave., Shahnazari St., Mirdamad
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 0947
Email
jalali.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Jalali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Madadkaran Ave., Shahnazari St., Mirdamad
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
jalali.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Jiryae
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Others
Street address
Madadkaran Ave., Shahnazari St., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
jiryaei.z@gmail.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