Investigation of the effect of medical insoles on the balance of unilateral below knee amputees
Design
An intervention study of the before and after type is performed on 10 individuals. Samples will be selected using the available sampling method. Accidentalization and study phase do not apply. The study is not blind.
Settings and conduct
This study is being conducted at Isfahan University of Medical Sciences, School of Rehabilitation, and the Center for Musculoskeletal Research. The information required in this study will be collected by laboratory observations. Data collection tools include: demographic information recording questionnaire and force plate. Individuals will stand on the force plate for one minute during each balance test. Data collection modes include: With insoles and open eyes, without insoles and open eyes, with insoles and closed eyes, without insoles and closed eyes. Each of these tests will be repeated 5 times for each person. So in total we will have 20 times to collect information. Each test has a code. The order of the tests will be random and by removing the codes inside the envelope.
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 knee
Intervention groups
The intervention group includes 10 people who receive medical insoles and each person's balance is compared to himself or herself before and after using insoles. The insoles for each person will fit the length of his or her foot inside the standard shoe according to the prosthesis material. In order to compensate for the difference in length due to the insole, a heel lift with the same material as ethylene vinyl acetate is used on the prosthetic side.
Main outcome variables
Balance of below knee amputee
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181113041636N3
Registration date:2020-05-13, 1399/02/24
Registration timing:prospective
Last update:2020-05-13, 1399/02/24
Update count:0
Registration date
2020-05-13, 1399/02/24
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
2020-05-30, 1399/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Medical Insole on Balance in Transtibial Amputees
Public title
Evaluation the Effect of Medical Insole on Balance in Transtibial Amputees
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Uilateral below knee amputees
Use a prosthesis for at least 6 hours during the day
The length of the stump should be between 5 and 7 inches
Amputation due to trauma
Have at least one year of prosthetic use
Use a SACH prosthetic foot
Exclusion criteria:
Bilateral amputation
Partial Foot, Knee or Above Knee Amputation
Having musculoskeletal and cardio-respiratory problems
Use aids such as a cane to walk
Use lower limb orthoses on the intact side
Stump-related problems include cracked skin, sores, bruises and blisters
Amputation due to vascular disease
People with foot supination
Having vision and vestibular problems
Having central neurological problems
Age
From 20 years old
Gender
Both
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 Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Azadi Square, Hezar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.MUI.RESEARCH.REC
Health conditions studied
1
Description of health condition studied
Balance in unilateral trans-tibial amputee people
ICD-10 code
S88
ICD-10 code description
Traumatic amputation of lower leg
Primary outcomes
1
Description
Static Balance
Timepoint
Balance measurement using medical insole and without the use of medical insole
Method of measurement
Force plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For this group, use full-length insoles made of ethylene vanilla acetate (EVA) with medium hardness, with medial longitudinal arch support and Heel Cup and metatarsal pad. These insoles fit the length of the person's foot and inside the standard shoe according to the prosthesis material.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculoskeletal Research Center
Full name of responsible person
Tahmores Tahmasbi
Street address
Faculty of Rehabilitation, West Door of Isfahan University of Medical Sciences, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
7346181746
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
Email
mui@mui.ac.ir
Web page address
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
Position
Faculty member
Latest degree
Ph.D.
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
Fax
+98 31 3668 7270
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
Position
Faculty member
Latest degree
Ph.D.
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
Fax
+98 31 3668 7270
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
Position
Faculty member
Latest degree
Ph.D.
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
Fax
+98 31 3668 7270
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