Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Children with spastic hemiparetic cerebral palsy will receive 20 sessions of therapeutic exercise using the designed mechanical ankle training device.
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Main outcome variables
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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
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Reason for update
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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).
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Acronym
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IRCT registration information
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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
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Registration date
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2026-02-18, 1404/11/29
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2026-03-01, 1404/12/10
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Expected recruitment end date
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2026-08-23, 1405/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Therapeutic Exercise Device in Children with Hemiparetic Cerebral Palsy
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 6 years old to 17 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
15
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2025-12-02, 1404/09/11
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1404.435
Health conditions studied
1
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Description of health condition studied
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Muscle Spasticity
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ICD-10 code
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G80.2
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ICD-10 code description
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Spastic hemiplegic cerebral palsy
Primary outcomes
1
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Description
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Change in plantar flexor spasticity
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Timepoint
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Baseline and after completion of 20 intervention sessions
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Method of measurement
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Ashworth Scale
Secondary outcomes
1
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Description
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Change in motor function
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Timepoint
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Fugl-Meyer Assessment Score
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Method of measurement
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Baseline and post-intervention
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The data are displayed after individuals have been anonymized
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When the data will become available and for how long
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six months after the publication of the results
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To whom data/document is available
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Will be available to researchers affiliated with academic and scientific institutions.
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Under which criteria data/document could be used
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The use of the data is permitted provided that the source is properly acknowledged.
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From where data/document is obtainable
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dr. Hamidreza Kobravi
hamidrezakobravi@gmail.com
dr Shabani
kosarshabaniv@gmail.com
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What processes are involved for a request to access data/document
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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)
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Comments
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