Design and Clinical Evaluation of a Novel Therapeutic Exercise Device for Reducing Plantar Flexor Spasticity in Children with Hemiparetic Cerebral Palsy
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General information
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Considering the limited number of eligible patients and that most participants are referred by Pediatric Neurology specialists, we propose expanding the age range of the study participants to facilitate patient recruitment and achieve the required sample size. Therefore, the age criterion for this clinical trial will be changed from 6–10 years to 6–17 years (from the beginning of 6 years of age up to the end of 17 years of age).
Considering the limited number of eligible patients and that most participants are referred by Pediatric Neurology specialists, we propose expanding the age range of the study participants to facilitate patient recruitment and achieve the required sample size. Therefore, the age criterion for this clinical trial will be changed from 6–10 years to 6–17 years (from the beginning of 6 years of age up to the end of 17 years of age).
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با توجه به محدودیت تعداد بیماران واجد شرایط ورود به مطالعه و نیز با در نظر گرفتن اینکه بیماران عمدتاً از طریق ارجاع همکاران محترم متخصص مغز و اعصاب به این مرکز معرفی میشوند، به منظور تسهیل فرآیند جذب نمونه و دستیابی به حجم نمونه مورد نیاز، محدوده سنی شرکتکنندگان در طرح از ۶ تا ۱۰ سال به بازه سنی ۶ تا ۱۷ سال (از ابتدای ۶ سالگی تا پایان ۱۷ سالگی) تغییر داده میشود.
با توجه به محدودیت تعداد بیماران واجد شرایط ورود به مطالعه و نیز با در نظر گرفتن اینکه بیماران عمدتاً از طریق ارجاع همکاران محترم متخصص مغز و اعصاب به این مرکز معرفی میشوند، به منظور تسهیل فرآیند جذب نمونه و دستیابی به حجم نمونه مورد نیاز، محدوده سنی شرکتکنندگان در طرح از ۶ تا ۱۰ سال به بازه سنی ۶ تا ۱۷ سال (از ابتدای ۶ سالگی تا پایان ۱۷ سالگی) تغییر داده میشود.
تشخیص بیمار فلج مغزی و فلج یکطرفهبدن توسط پزشکان فوق تخصص
برخورداری از حداقل توانمندیهای شناختی
برخورداری از قابلیتهای حرکتی در مفاصل زانو و لگن (این قابلیت بوسیله معاینه و تعیین نمره آزمون Fugl-Meyer تحت نظارت پزشک، تعیین خواهد شد)
عدم تشخیص سایر اختلالات عصبی و روانشناختی
بازه سنی 6 تا 10 سال
عدم استفاده از روش های درمانی که تداخل با اینطرح داشته باشند
تشخیص بیمار فلج مغزی و فلج یکطرفهبدن توسط پزشکان فوق تخصص
برخورداری از حداقل توانمندیهای شناختی
برخورداری از قابلیتهای حرکتی در مفاصل زانو و لگن (این قابلیت بوسیله معاینه و تعیین نمره آزمون Fugl-Meyer تحت نظارت پزشک، تعیین خواهد شد)
عدم تشخیص سایر اختلالات عصبی و روانشناختی
بازه سنی 6 تا 17 سال
عدم استفاده از روش های درمانی که تداخل با اینطرح داشته باشند
تشخیص بیمار فلج مغزی و فلج یکطرفهبدن توسط پزشکان فوق تخصص برخورداری از حداقل توانمندیهای شناختی برخورداری از قابلیتهای حرکتی در مفاصل زانو و لگن (این قابلیت بوسیله معاینه و تعیین نمره آزمون Fugl-Meyer تحت نظارت پزشک، تعیین خواهد شد) عدم تشخیص سایر اختلالات عصبی و روانشناختی بازه سنی 6 تا 1017 سال عدم استفاده از روش های درمانی که تداخل با اینطرح داشته باشند
Recruitment centers
#1
Name of recruitment center - English: Akbar Hospital
Name of recruitment center - Persian: بیمارستان اکبر
Full name of responsible person - English: Narges Hashemi
Full name of responsible person - Persian: نرگس هاشمی
Street address - English: Iran, Mashhad, Shahid Kaveh Blv, in front of Kaveh 14, Akbar Hopital
Street address - Persian: ایران، خراسان رضوی ،مشهد، بلوار شهید کاوه، مقابل شهید کاوه ١۴، بیمارستان اکبر
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177897157
Phone: +98 912 925 1781
Fax: +98 51 3870 9201
Email: Kosarshabaniv@gmail.com
Web page address: https://akbar.mums.ac.ir/
Name of recruitment center - English: Akbar Hospital
Name of recruitment center - Persian: بیمارستان اکبر
Full name of responsible person - English: Narges Hashemi
Full name of responsible person - Persian: نرگس هاشمی
Street address - English: Akbar Hospital, Shahid Kaveh Boulevard, Opposite Kaveh 14, Mashhad, Khorasan Razavi, 9177897157, Iran
Street address - Persian: ایران، خراسان رضوی، مشهد، بلوار شهید کاوه، مقابل کاوه ۱۴، بیمارستان اکبر، کدپستی 9177897157
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177897157
Phone: +98 912 925 1781
Fax: +98 51 3870 9201
Email: Kosarshabaniv@gmail.com
Web page address: https://akbar.mums.ac.ir/
Name of recruitment center - English: Akbar Hospital Name of recruitment center - Persian: بیمارستان اکبر Full name of responsible person - English: Narges Hashemi Full name of responsible person - Persian: نرگس هاشمی Street address - English: Iran, MashhadAkbar Hospital, Shahid Kaveh BlvBoulevard, in front ofOpposite Kaveh 14, Akbar HopitalMashhad, Khorasan Razavi, 9177897157, Iran Street address - Persian: ایران، خراسان رضوی،مشهد، بلوار شهید کاوه، مقابل شهید کاوه ١۱۴، بیمارستان اکبر، کدپستی 9177897157 City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9177897157 Phone: +98 912 925 1781 Fax: +98 51 3870 9201 Email: Kosarshabaniv@gmail.com Web page address: https://akbar.mums.ac.ir/
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Narges Hashemi
Full name of responsible person - Persian: نرگس هاشمی
Street address - English: Iran, Mashhad, Mashhad University of medical sciences, faculty of medicine
Street address - Persian: ایران، مشهد، دانشگاه علوم پزشکی مشهد، دانشکده پزشکی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3800 2000
Fax:
Email: Kosarshabaniv@gmail.com
Web page address: https://medical.mums.ac.ir/
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Narges Hashemi
Full name of responsible person - Persian: نرگس هاشمی
Street address - English: Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Khorasan Razavi, 9177948564, Iran
Street address - Persian: ایران، خراسان رضوی، مشهد، دانشگاه علوم پزشکی مشهد، دانشکده پزشکی، کدپستی 9177948564
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3800 2000
Fax:
Email: Kosarshabaniv@gmail.com
Web page address: https://medical.mums.ac.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Narges Hashemi Full name of responsible person - Persian: نرگس هاشمی Street address - English: Iran, MashhadFaculty of Medicine, Mashhad University of medical sciencesMedical Sciences, faculty of medicineMashhad, Khorasan Razavi, 9177948564, Iran Street address - Persian: ایران، خراسان رضوی، مشهد، دانشگاه علوم پزشکی مشهد، دانشکده پزشکی، کدپستی 9177948564 City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9177948564 Phone: +98 51 3800 2000 Fax: Email: Kosarshabaniv@gmail.com Web page address: https://medical.mums.ac.ir/
Protocol summary
Study aim
This study aims to develop and clinically evaluate a therapeutic exercise device designed to reduce plantar flexor spasticity in children with spastic hemiparetic cerebral palsy.
Design
This study is a single-arm, non-randomized, pre-post interventional clinical trial conducted on 15 children aged 6–10 years with spastic hemiparetic cerebral palsy.
Settings and conduct
Study Location and Procedures:
The study will be conducted at Akbar Hospital Clinic using a therapeutic exercise device designed by the Medical Engineering Research Center of Islamic Azad University, Mashhad.
Eligible children will be evaluated by pediatric neurology specialists. Baseline assessments will include the Ashworth Scale and Fugl-Meyer score.
Participants will undergo 20 sessions of 30-minute exercise using the device. Spasticity and functional outcomes will be measured before and after the intervention.
After completing the intervention, outcomes will be re-evaluated and compared with baseline data to assess the effectiveness of the device and exercises.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Spastic hemiplegic CP
Age 6–10
Minimal cognition
Knee and hip motor ability
No interfering treatments
No other neurological/psychological disorders
Exclusion Criteria:
No consent
Intervention groups
Children with spastic hemiparetic cerebral palsy will receive 20 sessions of therapeutic exercise using the designed mechanical ankle training device.
Main outcome variables
Change in plantar flexor spasticity measured by the Ashworth Scale at baseline and after completion of 20 intervention sessions.
Change in motor function measured by the Fugl-Meyer Assessment score at baseline and post-intervention.
General information
Reason for update
Considering the limited number of eligible patients and that most participants are referred by Pediatric Neurology specialists, we propose expanding the age range of the study participants to facilitate patient recruitment and achieve the required sample size. Therefore, the age criterion for this clinical trial will be changed from 6–10 years to 6–17 years (from the beginning of 6 years of age up to the end of 17 years of age).
Acronym
IRCT registration information
IRCT registration number:IRCT20250825066984N1
Registration date:2026-02-18, 1404/11/29
Registration timing:prospective
Last update:2026-06-08, 1405/03/18
Update count:1
Registration date
2026-02-18, 1404/11/29
Registrant information
Name
Kosar Shabani Varaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 925 1781
Email address
shabanivk4011@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-03-01, 1404/12/10
Expected recruitment end date
2026-08-23, 1405/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and Clinical Evaluation of a Novel Therapeutic Exercise Device for Reducing Plantar Flexor Spasticity in Children with Hemiparetic Cerebral Palsy
Public title
Therapeutic Exercise Device in Children with Hemiparetic Cerebral Palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of spastic hemiparetic cerebral palsy confirmed by a pediatric neurologist
Having at least minimal cognitive ability to follow instructions
Having motor capability in the knee and hip joints
No other diagnosed neurological or severe psychological disorders.
Age between 6 and 10 years;
Not receiving other interventions that may interfere with the study;
Exclusion criteria:
Withdrawal of consent at any stage of the study
Age
From 6 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
This study is a single-arm, non-randomized, pre-post interventional clinical trial. Participants will be evaluated at baseline and after completion of the intervention sessions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhhad University of Medical Sciences
Street address
Ethics Committee of Mashhad University of Medical Sciences, Mashhad University of Medical Sciences Campus, Mashhad, Khorasan Razavi, 9178195853, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178195853
Approval date
2025-12-02, 1404/09/11
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1404.435
Health conditions studied
1
Description of health condition studied
Muscle Spasticity
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
Change in plantar flexor spasticity
Timepoint
Baseline and after completion of 20 intervention sessions
Method of measurement
Ashworth Scale
Secondary outcomes
1
Description
Change in motor function
Timepoint
Fugl-Meyer Assessment Score
Method of measurement
Baseline and post-intervention
Intervention groups
1
Description
Participants will receive 20 sessions of therapeutic exercise using the designed mechanical ankle training device. The child will be seated, and the affected ankle will be positioned on a movable platform providing controlled mechanical stimulation to the soleus muscle.
Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Khorasan Razavi, 9177948564, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
Kosarshabaniv@gmail.com
Web page address
https://medical.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Narges Hashemi
Position
University professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Department of Pediatrics, Qaem Hospital, Ahmad Abad Avenue, Mashhad, Khorasan Razavi, 9919991766, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3801 2469
Email
hashemin@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Narges Hashemi
Position
University professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Department of Pediatrics, Qaem Hospital, Ahmad Abad Avenue, Mashhad, Khorasan Razavi, 9919991766, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3801 2469
Email
hashemin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kosar Shabani Varaki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Khorasan Razavi, 9177948564, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
Kosarshabaniv@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data are displayed after individuals have been anonymized
When the data will become available and for how long
six months after the publication of the results
To whom data/document is available
Will be available to researchers affiliated with academic and scientific institutions.
Under which criteria data/document could be used
The use of the data is permitted provided that the source is properly acknowledged.
From where data/document is obtainable
dr. Hamidreza Kobravi
hamidrezakobravi@gmail.com
dr Shabani
kosarshabaniv@gmail.com
What processes are involved for a request to access data/document
They must email the designated contacts, introduce themselves, and state their request. After the email is reviewed, the materials will be sent to them if possible. (within one month)