UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059574 |
|---|---|
| Receipt number | R000068140 |
| Scientific Title | The Effect of a Comprehensive Corrective Exercise Protocol with and without instruction cures on Lumbar-Pelvic Kinematics and Foot Posture in Individuals with Foot hyper Pronation |
| Date of disclosure of the study information | 2025/10/29 |
| Last modified on | 2025/10/29 02:46:40 |
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Basic information
Public title
The Effect of a Comprehensive Corrective Exercise Protocol with and without instruction cures on Lumbar-Pelvic Kinematics and Foot Posture in Individuals with Foot hyper Pronation
Acronym
Effect of a Comprehensive Corrective Exercise Protocol on Lumbar-Pelvic Kinematics and Foot Posture
Scientific Title
The Effect of a Comprehensive Corrective Exercise Protocol with and without instruction cures on Lumbar-Pelvic Kinematics and Foot Posture in Individuals with Foot hyper Pronation
Scientific Title:Acronym
Effect of a Comprehensive Corrective Exercise Protocol on Lumbar-Pelvic Kinematics and Foot Posture
Region
| Asia(except Japan) |
Condition
Condition
In this study, 45 individuals with foot hyper pronation were selected as a statistical sample and randomly assigned to 3 groups (comprehensive corrective exercises, comprehensive corrective exercises with instruction cues, and control). Corrective exercises were performed and Kinematic data were recorded. At the beginning and end of the training program, pre-test and post-test were performed in 3 groups.
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of a comprehensive corrective exercise protocol with and without corrective instructions on lumbopelvic kinematics and foot posture in people with foot pronation.
Basic objectives2
Others
Basic objectives -Others
-Investigating the effect of a comprehensive corrective exercise protocol with and without corrective instructions on lumbopelvic kinematics in people with foot pronation.
-Investigating the effect of a comprehensive corrective exercise protocol with and without corrective instructions on foot posture in people with foot pronation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The results of the present study showed that performing corrective exercises can improve the navicular pronation index and lower back kinematic indices in people with foot pronation abnormalities.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Control group 1: without training
Interventions/Control_2
Experimental group 2:Comprehensive Corrective Exercise Protocol with instruction cures.
Interventions/Control_3
Experimental group 3:Comprehensive Corrective Exercise Protocol without instruction cures.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18-30 years with increased foot pronation;
Normal body mass index (BMI);
Having a navicular drop of more than 10 mm;
Score higher than 5 on the six-item static foot posture index.
Key exclusion criteria
Under treatment with foot supports or any type of exercise therapy;
Failure to participate in the sessions measuring the dependent variables of the study in the pre- or post-test;
Failure to participate in two consecutive training sessions and three non-consecutive training sessions;
No chronic pain due to structural or functional problems in the lower extremities and lumbo-pelvic complex;
No neurological disorders affecting gait such as neuropathy or other sensory disorders.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Malihe |
| Middle name | Hadad |
| Last name | Nezhad |
Organization
Kharazmi university
Division name
Department of Sports Injury and Corrective Exercises
Zip code
1571914911
Address
Tehran, Enghelab St., South Mofateh St., Kharazmi University
TEL
0989123469464
m.Hadadnezhad@yahoo.com
Public contact
Name of contact person
| 1st name | Pariya |
| Middle name | Aghapour |
| Last name | Bonab |
Organization
Kharazmi University
Division name
Department of Sports Injury and Corrective Exercises
Zip code
5551776658
Address
Iran, East Azerbaijan, Bonab, Imam St., Laleh Blvd., Takhti Alley
TEL
098386654323
Homepage URL
pariya79.aghapour@yahoo.com
Sponsor or person
Institute
Kharazmi University
Institute
Department
Personal name
Pariya Aghapour Bonab
Funding Source
Organization
Kharazmi University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Iran
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kharazmi University
Address
Tehran, Qods City (West), simay Iran Street-Central Head
Tel
0982181455618
ethics@ssrc.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
There is a plan to release the protocol, but the URL has not been determined yet.
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068140
