The effect of smart wearable insoles on improvement of Gait Training in children with idiopathic Toe Walking, compared to the control group including physiotherapy and occupational therapy and the placebo group including the use of simple medical insoles , A clinical trial study
The effect of smart insoles based on Gait Training in improving the walking of children with idiopathic toe walking compared to the control group including physiotherapy and occupational therapy and the placebo group including the use of simple medical insoles
Design
This study is a randomized and double-blind clinical trial.This study is divided into 3 treatment groups. The first group: the intervention group, which includes the use of smart medical insoles, the second group: the control group, which includes physiotherapy and occupational therapy, and the third group: the placebo group, which includes the use of simple medical insoles.Patients in the intervention group receive insoles containing pressure sensors to analyze walking patterns. These people undergo the gait retraining program using the feedback of these insoles for 8 weeks
Settings and conduct
In physical medicine and orthopedic clinics of Bahrami and Shariati hospitals in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 2 to 14 years old with a definite diagnosis of Idiopathic toe walking
exclusion criteria
1. Having any background disease including orthopedic, neurological, psychological and other diseases.
2. Cases that use insoles for more than a week and for less than 6 hours a day will be excluded from the study.
3. In the last 6 months, he has not received any treatment, including physiotherapy, occupational therapy, etc.
Intervention groups
Children 2 to 14 years old with a definite diagnosis of Idiopathic toe walking
Main outcome variables
The amount of ankle dorsiflexion in both passive and active states
Gate analysis or walking check
Distance-time or spatiotemporal parameters
The percentage of parents' satisfaction with your children's walking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241223064140N1
Registration date:2025-04-10, 1404/01/21
Registration timing:prospective
Last update:2025-04-10, 1404/01/21
Update count:0
Registration date
2025-04-10, 1404/01/21
Registrant information
Name
Mohammad Sadegh Dehghan Nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3355 3700
Email address
sadegh.nasiri73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-21, 1404/06/30
Expected recruitment end date
2026-09-21, 1405/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of smart wearable insoles on improvement of Gait Training in children with idiopathic Toe Walking, compared to the control group including physiotherapy and occupational therapy and the placebo group including the use of simple medical insoles , A clinical trial study
Public title
The effect of smart wearable insoles on the improvement of Gait Training in improving the gait of children with idiopathic Toe Walking
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 2 to 14 years
definite diagnosis of idiopathic Toe Walking.
Exclusion criteria:
Age
From 2 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the data analyst will be unaware of the type of intervention applied to the patients.
The attending physician and the people involved in providing the intervention will be aware of the grouping of the patients.
Placebo
Not used
Assignment
Parallel
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
No.23, 16 Azar Ave., Keshavarz Blvd.Tehran wn
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2024-07-13, 1403/04/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.177
Health conditions studied
1
Description of health condition studied
Idiopathic toe walking
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Analysis of ankle dorsiflexion range in both passive and active states
Timepoint
At the beginning and 8 weeks and 3 months later
Method of measurement
by goniometer
Secondary outcomes
1
Description
Satisfaction level of parents and doctor
Timepoint
At the beginning and 8 weeks and 3 months later
Method of measurement
Questions from parents and doctors
Intervention groups
1
Description
Intervention group: Using smart medical insoles
Category
Treatment - Devices
2
Description
Control group: Physiotherapy and occupational therapy
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Mohammad Sadegh Dehghan Nasiri
Street address
Jalale ale ahmad Ave, North karegar Blvd., Tehran Town
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
Ramin Kordi
Street address
6th floor of Research and Technology Vice Chancellor, Central Organization of the University, corner of Quds St.Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
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 Sadegh Dehghan Nasiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 16,Dideh var alley,Biglo tehrani Ave,17 Shahrivar Ave,Tehran town
City
Tehran
Province
Tehran
Postal code
1174846796
Phone
+98 21 3355 3700
Email
sadegh.nasiri73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Dehghan Nasiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 16, Dideh var alley, Biglo tehrani Ave,17 Shahrivar Ave,Tehran town
City
Tehran
Province
Tehran
Postal code
1174846796
Phone
+98 21 3355 3700
Email
sadegh.nasiri73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Dehghan Nasiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 16,Dideh var alley, Biglo tehrani Ave,17 shahrivar Ave, Tehran town
City
Tehran
Province
Tehran
Postal code
1174846796
Phone
+98 21 3355 3700
Email
sadegh.nasiri73@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
No - There is not 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 study data and their analysis can be shared after the end of the study and after making it nonidentifiable
When the data will become available and for how long
The access period starts 1 year after the results are published
To whom data/document is available
It is accessible to all people
Under which criteria data/document could be used
It is accessible to all people
From where data/document is obtainable
sadegh.nasiri73@gmail.com
What processes are involved for a request to access data/document