Effect of a sand training on the kinetics, amplitud of muscular electrical activity and body image in individuals with pronated feet
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Subjects' familiarity with the method of testing is carried out in the health center of Mohaghegh Ardabili University, in two stages of pre-test and post-test. Installing surface electrodes on the lower extremities of the modules and performing the process of walking and running on the force plate. How to double-blind which neither the tester nor the Subject is aware of this process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A navicular drop of more than 10 mm, a foot posture index of greater than 10, and age range between 18-30 years old.
Exclusion criteria: The presence of limb length discrepancies of more than 5 mm, muscle spasm, neuromuscular disorders, orthopedic-related diseases or any previous surgeries in the lower limbs and trunk.
Intervention groups
Intervention group: Pronation complication group (barefoot walking and running before and after training sessions) Control group: Pronation complication group (walking and running barefoot before and after eight weeks without intervention)
Main outcome variables
Electric activity of the muscle, co-contraction and ground reaction force
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191211045704N1
Registration date:2020-02-25, 1398/12/06
Registration timing:prospective
Last update:2020-02-25, 1398/12/06
Update count:0
Registration date
2020-02-25, 1398/12/06
Registrant information
Name
Amir Fatollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3582 2100
Email address
amir.af@student.uma.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2641-03-01, 2019/12/10
Expected recruitment end date
2641-05-10, 2020/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a sand training on the kinetics, amplitud of muscular electrical activity and body image in individuals with pronated feet
Public title
Effect of a sand training in individuals with flat foot
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
pronated foot
male
No history of surgery
Exclusion criteria:
People with knee injuries
Elderly and children
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used to allocate study participants into experimental and control groups. Of note, participants will be blinded to group allocation.
During the randomization process, a set of sealed, opaque envelopes will be used to ensure the
concealment of allocation. Each envelop will be contained a card indicating to which group the subject would allocated.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, the main researcher and the evaluator, do not interfere in the process of data recording and analysis. The participant will not be aware of the respective
group they will be allocated to. A naïve person that will not have a role in this study will be responsible for the allocation process.
One examiner will determine whether a participant will be eligible for inclusion in the trial, while the other will carried
out gait analyses of the eligible participants. Both examiners will be unaware of group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Daneshghah Ave, University of Mohaghegh Ardebili
City
Ardabil
Province
Ardabil
Postal code
4551733411
Approval date
2640-07-03, 2019/04/12
Ethics committee reference number
IR.ARUMS.REC.1398.484
Health conditions studied
1
Description of health condition studied
over pronation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pronated foot
Timepoint
8 week
Method of measurement
force plate Bertec and surface EMG Bio-system
Secondary outcomes
1
Description
flat foot
Timepoint
8 week
Method of measurement
force plate Bertec and surface EMG Bio-system
Intervention groups
1
Description
Intervention group: During the eight weeks (3 sessions per week) of the intervention, the intervention group will be performed sand running training program that is continuous jogging, striding, and bounding, galloping, short sprints. Every session will be started with a warm-up and stretching session for five minutes and will be ended with a warm-down session for five minutes. Total training duration is 50 minutes per session.
Category
Rehabilitation
2
Description
Control group: The control group will not perform any exercise and will be re-evaluated after 8 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Mohaghegh Ardabili
Full name of responsible person
Amir Fatollahi
Street address
Daneshghah Ave.,University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
4551733411
Phone
+98 24 3582 2100
Email
amiraf14618@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Abolfazl Bezaat pour
Street address
Daneshghah Ave.,University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
4551733411
Phone
+98 45 3150 5649
Email
a.bezaatpour@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Daneshghah Ave., University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
Email
amiralijafarnezhad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Associate professor Biomechanics
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Daneshghah Ave, University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
Email
amiralijafarnezhad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Daneshghah Ave, University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
Email
amiralijafarnezhad@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available