Determining the effect of medical insoles with lateral wedges on the knee adduction moment on the intact side of people with unilateral below-knee amputation.
Design
An intervention study of the before and after the type is performed on 10 individuals. Samples will be selected using the available sampling method from among those who refer to technical orthopedic centers.
Settings and conduct
This study will be conducted at Isfahan University of Medical Sciences, Faculty of Rehabilitation, Musculoskeletal Research Center. The information required in this study will be collected through laboratory observations. Data collection tools include demographic information recording questionnaire and force plate device. Participants will walk on a 5-meter-long force plate to perform the test once with a medical insole with a lateral wedge and once without a medical insole. To reduce the measurement error, each test will be repeated 5 times. The sequence of tests will be random.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with unilateral below-knee amputation Exclusion criteria: healthy or amputated individuals other than under the unilateral below the knee.
Intervention groups
The intervention group will include 10 people who will receive a medical insole with a lateral wedge. knee adduction moment in the intact side will be compared to before and after using the insole.
Main outcome variables
Knee adduction moment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181113041636N2
Registration date:2020-05-10, 1399/02/21
Registration timing:prospective
Last update:2020-05-10, 1399/02/21
Update count:0
Registration date
2020-05-10, 1399/02/21
Registrant information
Name
tahmoures tahmsebi notoraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5015
Email address
t_tahmasbi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the lateral wedge on the knee adduction moment in the sound side of unilateral Trans-Tibial amputees
Public title
The effect of the lateral wedge on the knee adduction moment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The amputation of the lower limb is below the knee and unilateral.
The minimum time to use a prosthesis during the day is 6 hours.
Stump length is normal and natural.
Amputation due to trauma.
Be at least 30 years old.
Have at least 10 years of prosthetic use.
Use on SACH prosthetic foot.
Exclusion criteria:
Grade 3 and 4 osteoarthritis of the knee.
Partial foot, knee disarticulation, above knee amputation.
Bilateral amputation.
Problems in neuromusculoskeletal, psychology and respiratory cardiac.
Using from the cane.
Use of lower limb orthotics.
Problems in the skin of the stump.
Amputation due to Vascular Disease.
Having foot supination.
Having foot pronation.
Having a Knock-knee in intact side.
Muscle contracture in intact side.
Having the vision and vestibular problems.
Age
From 30 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjerib St ., Azadi Sq ., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-12-13, 1398/09/22
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.517
Health conditions studied
1
Description of health condition studied
Osteoarthritis in the sound limb of the knee of unilateral trans-tibial amputee people.
ICD-10 code
M17.5
ICD-10 code description
Other unilateral secondary osteoarthritis of knee
Primary outcomes
1
Description
knee adduction moment.
Timepoint
Knee adduction moment measurement using medical insole with a lateral wedge and without the use of a medical insole.
Method of measurement
Force plate.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention will be is to use full-length insoles made of medium hardness ethylene vanilla acetate (EVA) with medial longitudinal arch support, Heel Cup, and lateral wedge. These insoles which will be made according to the length of the person's foot and prosthesis material will be laid inside the standard shoe. Participants will then wear the shoes and walk 5 meters on the force plate, this work will be repeated 5 times to reduce the measurement error.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculoskeletal Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Tahmores Tahmasebi Notarki
Street address
Faculty of Rehabilitation, West Door of Isfahan University of Medical Sciences, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3792 5229
Fax
+98 31 3668 7270
Email
muigaitlab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Tahmoures Tahmasebi Notarki
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5015
Email
Tahmasebi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmoures Tahmasebi Notarki
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5015
Email
Tahmasebi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmoures Tahmasebi notarki
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5015
Email
Tahmasebi@rehab.mui.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
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