Comparision between puzzle insole and conventional four-layer insole with offloading rocker sole shoe on dynamic balance and spatio-temporal parameters of gait in patients with diabetic foot ulcers
Comparision of the effect of puzzle insole and conventional four-layer insole
with offloading rocker sole shoe on dynamic balance and spatio-temporal
parameters of gait in patients with diabetic foot ulcers
Design
A crossover clinical trial in which each person receives three interventions.
Settings and conduct
Balance and time-spatial parameters of gait test will be done with systematic analysis treadmill at Tehran Sport Sciences Research Institute
Participants/Inclusion and exclusion criteria
Inclusion criteria؛ Shallow diabetic plantar ulcer in the forefoot in patients 40 to 60 years old who do not have a history of balance disorders or a history of taking medications affecting balance.
Exclusion criteria؛ patient's disinclination to cooperate or inability to walk
Intervention groups
Intervention 1:puzzle insole in offloading 20 rocker sole shoes
Intervention 2:conventional four-layer insole in offloading 20 rocker sole shoes
Intervention 3:control: the patient's own shoes, which are low top with flat insoles
Main outcome variables
Step length, step width, number of steps, step time, percentage of stance phase time, mid-stance phase time percentage, anterior-posterior shift of the center of pressure, lateral shift of the center of pressure, standard deviation of the center of pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240405061417N1
Registration date:2024-08-06, 1403/05/16
Registration timing:registered_while_recruiting
Last update:2024-08-06, 1403/05/16
Update count:0
Registration date
2024-08-06, 1403/05/16
Registrant information
Name
AKRAM TADI BENI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2640 5626
Email address
tadibeni.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision between puzzle insole and conventional four-layer insole with offloading rocker sole shoe on dynamic balance and spatio-temporal parameters of gait in patients with diabetic foot ulcers
Public title
Comparison of the effect of two types of offloading insoles on the balance of patients with diabetic foot ulcers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with foot ulcers only due to neuropathy
The ulcer of the forefoot
The maximum size of the ulcer is 2x2 cmm
The age of patients should be between 40 and 60 years
Diabetic foot ulcer is shallow
No amputation of fingers
Absence of disease due to imbalance such as Parkinson's, MS, vestibular disorders or similar cases
Not taking drugs that affect balance
Have no history of using the researched off-loading shoes
Exclusion criteria:
The ulcer is on the foot or leg or in the hindfoot
The vascular ulcers or neurovascular ulcers
The ulcer has involved the bone
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
3
The balance test for each participant will be done once with the patient's own shoes, once with off-loading shoes with 20-degree rocker sole and conventional four-layer soles, and once with off-loading shoes with 20-degree rocker sole and four-layer puzzle soles.
Randomization (investigator's opinion)
Randomized
Randomization description
In this cross-over study, the sequence of interventions and experimental conditions will be randomly determined as follows: First, a list of all participants will be prepared. Then, a random number generation software will be utilized to determine the sequential order for each participant. For this purpose, randomization algorithms available in R software will be used. Each participant will be assigned a unique random number that specifies the order of interventions and experimental conditions. The process will involve assigning even numbers to one order and odd numbers to another.
The results of the random assignment will be documented in separate tables, and the final order for each participant will remain confidential, with no review by other researchers, to ensure fair and random allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.IUMS.REC.1402.375
Health conditions studied
1
Description of health condition studied
Diabetic polyneuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
Step width: It means the distance between the line of progress of the left foot and the line of progress of the right foot
Timepoint
Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole.
Method of measurement
In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software
2
Description
Step legnth: The length measured parallel to the forward line of the body from the heel contact of one foot to the heel contact of the other foot
Timepoint
Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole.
Method of measurement
In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software
3
Description
Step time: The time interval between the heel contact of one foot with the ground and the heel contact of the opposite foot with the ground
Timepoint
Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole.
Method of measurement
In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software
4
Description
Stance time percentage :This phase starts when the foot is in contact with the ground and with the complete separation of the same foot from the groundIt ends. The stance phase constitutes approximately 60% of the walking phase
Timepoint
Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole
Method of measurement
In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software
5
Description
The time percentage of the midstance phase: in observation; This phase of walking starts with the separation of the toes of the opposite foot from the ground and continues until the heel of the progressive foot is in contact with the ground and accounts for 29 to 37% of walking
Timepoint
Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole
Method of measurement
In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software
6
Description
The number of steps per unit of time (cadence): is the frequency of steps
Timepoint
Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole
Method of measurement
In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software
7
Description
Lateral shift of the center of pressure: indicating the movement direction of the center of pressure to the left and right
Timepoint
Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole
Method of measurement
In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software
8
Description
Anterior-posterior shift of the center of pressure: the direction of movement of the center of pressure is anterior-posterior
Timepoint
Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole
Method of measurement
In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software
9
Description
Standard deviation of the center of pressure: The standard deviation of the center of pressure is obtained by calculating the displacement of all steps
Timepoint
Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole
Method of measurement
In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: offloading shoes with a 20-degree rocker sole with a conventional four-layer insole. Rocker insole shoe is a type of footwear modification where the sole of the shoe is curved. Its purpose is to allow the body's center of mass to roll over the support surface. The conventional four-layer insole used in this research consists of an upper layer of plastazote with a hardness of A30 in contact with the foot, a polyethylene foam layer with a hardness of A40 as the second layer, a polyethylene foam layer with a hardness of A50 as the third layer, and a shear force reduction layer made of pron located underneath all the layers.
Category
Rehabilitation
2
Description
Intervention group: offloading shoes with a 20-degree rocker sole with a puzzle four-layer insole. Rocker insole shoe is a type of footwear modification where the sole of the shoe is curved. Its purpose is to allow the body's center of mass to roll over the support surface. The conventional four-layer insole used in this research consists of an upper layer of plastazote with a hardness of A30 in contact with the foot, a polyethylene foam layer with a hardness of A40 as the second layer, a polyethylene foam layer with a hardness of A50 as the third layer, and a shear force reduction layer made of pron located underneath all the layers.
Category
Rehabilitation
3
Description
Control group: The patient's own shoes, which are low top with flat insoles
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
IUMS School of Rehabilitation Science
Full name of responsible person
Dr Hasan Saeedi
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
hassan-saeedi2@yahoo.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Reza Falak
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Akram Tadi Beni
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Orthosis and prosthesis
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
15459 13487
Phone
+98 21 2640 5626
Email
tadibeni.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hassan Saeedi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis and Prosthesis
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
15459 13487
Phone
+98 21 2222 2059
Email
hassan-saeedi@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akram Tadi Beni
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Orthosis and prosthesis
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
15459 13487
Phone
+98 21 2640 5626
Email
tadibeni.a@iums.ac.ir
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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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