Development of Rehabilitation Protocols Based on Predictive Modeling of the Effects of Mechanical Vibrations and Robotics on Neuromuscular Control and Gait Improvement in Children with Cerebral Palsy
Main Objective
To evaluate the therapeutic effects of mechanical vibrations on ankle joint neuromuscular abnormalities and gait disorders in children with Cerebral Palsy (CP) using a rehabilitation robot.
Design
A total of 36 patients will be randomly allocated into two groups. The randomization process will be performed using the RAND() function in Microsoft Excel.
Settings and conduct
A total of 36 patients will be randomly allocated into two groups. The randomization process will be performed using the RAND() function in Microsoft Excel.
Participants/Inclusion and exclusion criteria
Inclusion Criterion:
Children diagnosed with spastic hemiplegic and diplegic Cerebral Palsy (CP).
Exclusion Criteria:
Severe intellectual disability.
A history of uncontrolled epilepsy or untreated seizures.
Intervention groups
The intervention group will undergo treatment with a neuromuscular rehabilitation robot for a duration of 2 months, with sessions held 3 times a week for 30 minutes each. The appropriate range of motion (ROM) for the individual's ankle joint will be determined. During the treatment session, low-amplitude, high-frequency vibrations will be applied to the individual, both throughout the entire range of motion and statically at the end-range of dorsiflexion.
The control group: During this period, children in the control group will receive the same amount of conventional occupational therapy, with a focus on reducing ankle spasticity.
Main outcome variables
Neuromuscular parameters of the ankle joint
Kinetic and kinematic parameters of the ankle joint
Spatiotemporal gait parameters
Dynamic balance
Static balance
Clinical test parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250629066292N1
Registration date:2025-07-21, 1404/04/30
Registration timing:prospective
Last update:2025-07-21, 1404/04/30
Update count:0
Registration date
2025-07-21, 1404/04/30
Registrant information
Name
Mohammad Mehdi Mirbagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6646 6383
Email address
mehdi.northwestern@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-08-11, 1404/05/20
Expected recruitment end date
2027-08-11, 1406/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development of Rehabilitation Protocols Based on Predictive Modeling of the Effects of Mechanical Vibrations and Robotics on Neuromuscular Control and Gait Improvement in Children with Cerebral Palsy
Public title
Development of Rehabilitation Protocols Based on Predictive Modeling of the Effects of Mechanical Vibrations and Robotics on Neuromuscular Control and Gait Improvement in Children with Cerebral Palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with spastic hemiplegic and diplegia Cerebral Palsy (CP).
Ability to participate in the scheduled treatment and assessment sessions.
Ability to communicate and follow instructions.
Exclusion criteria:
Severe intellectual disability.
A history of uncontrolled epilepsy or untreated seizures.
Age
From 3 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly allocated to either an intervention group or a control group. The randomization process will be performed using the RAND() function in Microsoft Excel.
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
Tehran University of Medical Sciences Research Ethics Committee
Street address
Poursina st, Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1417466891
Approval date
2025-05-11, 1404/02/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.129
Health conditions studied
1
Description of health condition studied
Children with spastic hemiplegic Cerebral Palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
2
Description of health condition studied
Children with spastic diplegic Cerebral Palsy
ICD-10 code
G80.1
ICD-10 code description
Spastic diplegic cerebral palsy
Primary outcomes
1
Description
Stiffness
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Neuromuscular rehabilitation robot
Secondary outcomes
1
Description
Active range of motion
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Position sensor of the neuromuscular rehabilitation robot.
2
Description
Maximum voluntary contraction force
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Torque sensor of the neuromuscular rehabilitation robot.
3
Description
Speed of voluntary joint movement
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Position sensor of the neuromuscular rehabilitation robot.
4
Description
Ankle joint angles
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Using marker positions in the motion capture lab
5
Description
Maximum step height
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Using marker positions in the motion capture lab
6
Description
Center of pressure fluctuations
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Force plate
7
Description
Static stability
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Force plate
8
Description
Timed up and Go
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Stopwatch
9
Description
10-meter walk test
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Stopwatch
10
Description
6-minute walk test
Timepoint
Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up)
Method of measurement
Meter
Intervention groups
1
Description
Intervention group: The intervention group will undergo treatment with the neuromuscular rehabilitation robot for 30 minutes per session, 3 times a week, over a two-month period. Participants will be seated on the adjustable chair of the robot, and their ankle will be secured in a custom brace to ensure the ankle joint's axis of rotation is aligned with that of the robot's motor .The appropriate range of motion (ROM) for the individual's ankle joint is determined. During the treatment session, low-amplitude, high-frequency vibrations are applied to the individual, both throughout the entire range of motion and statically at the end-range of dorsiflexion.
Category
Rehabilitation
2
Description
Control group: Children in the control group will receive a conventional occupational therapy program for the same duration and frequency, with a focus on reducing ankle spasticity.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Fakhre Sadeq Rehabilitation Center
Full name of responsible person
Shahrbanoo ,Mojtahedi
Street address
No. 42, Alipour Karami St., Mohandes El-Mamalek St., Jomhuri St.
City
Tehran
Province
Tehran
Postal code
1146733711
Phone
+98 21 3687 0766
Email
mehdi.northwestern@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research and Technology Management, Tehran University of Medical Sciences
Street address
Poursina st, Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1417466891
Phone
+98 21 8891 2090
Email
mehdi.northwestern@gmail.com
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
59
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 Mehdi Mirbagheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Poursina st, Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8891 2090
Fax
Email
mehdi.northwestern@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Mirbagheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Poursina st, Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8891 2090
Fax
Email
mehdi.northwestern@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Mirbagheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Poursina st, Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8891 2090
Fax
Email
mehdi.northwestern@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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available