Evaluating the effect of the comprehensive drug protocol for spasticity in cerebral palsy patients in terms of gait analysis, clinical examination, radiographic changes, complications and quality of life.
Determining the effectiveness of a comprehensive drug treatment protocol for spasticity in patients with cerebral palsy. Analysis of gait analysis, clinical examination, radiographic examination, drug side effects, quality of life.
Design
single arm group randomized trial,phase 2,group design of 31 patients
Settings and conduct
This study will be conducted in the orthopedic clinics of Tehran University of Medical Sciences on spastic cerebral palsy patients who have been included in the study according to the inclusion and exclusion criteria, based on a drug therapy protocol.
Participants/Inclusion and exclusion criteria
Patients with spastic cerebral palsy with or without a history of previous drug treatment and without a history of surgery within the past year.
Intervention groups
In this study, the effectiveness of drug therapy in cerebral palsy patients who were included in the study according to the inclusion and exclusion criteria will be examined according to the following protocol.
Choice of treatment type:
-Generalized spasticity treatment
1-First line: Baclofen (maximum dose 2.5mg/kg/day), Tizanidine (4mg/kg/day)
2-Second line: Dantrolene (12mg/kg/day), Diazepam (0.01-0.3mg/kg/day)
3-Third line (intraspinal baclofen (50 micrograms on the first day, 75 micrograms on the second day, 100 micrograms on the third day)
-Treatment with local aim (both in generalized and local spasticity)
1-Botulinum toxin (upper, lower limbs): 30U/kg
After giving the above drugs to each of the patients with the specified dosage in the first three visits, 3 and 6 months later, the patients are examined with examination and radiology and the results of the study are recorded
Main outcome variables
spasticity ؛Range of motion؛drug side effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241215064059N1
Registration date:2025-01-04, 1403/10/15
Registration timing:prospective
Last update:2025-01-04, 1403/10/15
Update count:0
Registration date
2025-01-04, 1403/10/15
Registrant information
Name
Mohammad Amin Choobdar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4424 4601
Email address
dr.amin.choobdar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-17, 1403/10/28
Expected recruitment end date
2025-02-16, 1403/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of the comprehensive drug protocol for spasticity in cerebral palsy patients in terms of gait analysis, clinical examination, radiographic changes, complications and quality of life.
Public title
Investigating the effect of drug treatment protocol in cerebral
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with spastic cerebral palsy
with or without a history of previous drug treatment
without a history of surgery within the past year
Exclusion criteria:
Patients who have not returned for a follow-up visit during this period
Patients who have had surgery within the past year
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences
Street address
south Eskandari,Shokoufe ave
City
Tehran
Province
Tehran
Postal code
1319764853
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.222
Health conditions studied
1
Description of health condition studied
spastic cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
spasticity
Timepoint
The beginning of the study, 3 and 6 months later
Method of measurement
Ashworth scale
2
Description
range of motion
Timepoint
The beginning of the study, 3 and 6 months later
Method of measurement
Goniometer
3
Description
drug side effect
Timepoint
The beginning of the study, 3 and 6 months later
Method of measurement
Medication side effects questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, the effectiveness of drug therapy in cerebral palsy patients who were included in the study according to the inclusion and exclusion criteria will be examined according to the following protocol. Selection of treatment type: - Treatment of generalized spasticity 1- First line: Baclofen (maximum dose 2.5 mg/kg/day), Tizanidine (4 mg/kg/day) 2- Second line: Dantrolene (12 mg/kg/day), Diazepam (0.01-0.3 mg/kg/day) 3- Third line (intraspinal baclofen (50 micrograms on the first day, 75 micrograms on the second day, 100 micrograms on the third day) - Treatment with local aim (both in generalized and local spasticity) 1- Botulinum toxin {Dysport, Masport, Dyston} (upper, lower limbs): 30 U/kg Treatment based on specific conditions - Pain (botulinum toxin, Tizanidine, oral baclofen, Diazepam, Dantrolene, intraspinal baclofen) - Disorder Sleep (tizanidine, oral baclofen, diazepam) - mixed type with dystonia (botulinum toxin, oral baclofen, diazepam) - post-operative pain due to spasm (diazepam, botulinum toxin, oral baclofen) - seizures (tizanidine, diazepam * Caution regarding the use of baclofen, dantrolene and intrathecal baclofen; After giving the above drugs to each of the patients with the specified dosage in the first three visits, 3 and 6 months later, the patients are examined with examination and radiology and the results of the study are recorded. If the drug results improve, it is continued, and if the results are not favorable, the second line is started.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Theran Imam khomeini hospital complex
Full name of responsible person
Mohamad Amin Choobdar Omrani
Street address
Keshavarz blv
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2613
Email
Imamhospital@tums.ac.ir
2
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Mohamad Amin Choobdar Omrani
Street address
north kargar ave
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sina Rezaei
Street address
poorsina ave
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 8163 3619
Fax
Email
aminch2009@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amin Choobdar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Eskandari
City
Tehran
Province
Tehran
Postal code
1319764853
Phone
+98 11 4424 4601
Fax
Email
dr.amin.choobdar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amin Choobdar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Eskandari
City
Tehran
Province
Tehran
Postal code
1319764853
Phone
+98 11 4424 4601
Fax
Email
dr.amin.choobdar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amin Choobdar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Eskandari
City
Tehran
Province
Tehran
Postal code
1319764853
Phone
+98 11 4424 4601
Fax
Email
dr.amin.choobdar@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
The access period begins immediately after the results are published.
To whom data/document is available
All researchers in the field of medical and pharmaceutical sciences
Under which criteria data/document could be used
Researchers in the fields of medical and pharmaceutical sciences have permission to access the data. There are no restrictions on data analysis.
From where data/document is obtainable
mohammad amin choobdar
09200567515
dr.amin.choobdar@gmail.com
What processes are involved for a request to access data/document
پس از تماس و اعلام درخواست ابتدا مدارک مربوط به فرد درخواست دهنده جهت تایید ارسال شده و طی یک هفته داده ها از طریق ایمیل تحویل خواهد شد