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Evaluating The immediate Effect of Using Two density Insoles with Lateral Wedge Embedded inside a Novel Neoprene Sock on Pain, Quality of Life, and Biomechanical Parameters of the Knee Joint During walking in the Elderly with Medial Compartment Knee Osteoarthritis

Protocol summary

Study aim
Evaluating The immediate Effect of Using Two density Insoles with Lateral Wedge Embedded inside a Novel Neoprene Sock on Pain, Quality of Life, and Biomechanical Parameters of the Knee Joint During walking in the Elderly with Medial Compartment Knee Osteoarthritis
Design
Repeated measures one-grouped before-after trial, sample size =30
Settings and conduct
Sampling will be done by the sample of convenience method in Hamadan city. The biomechanics laboratory of the Boali University of Hamadan and the ergonomics laboratory of the Hamedan University of Medical Sciences will be equipped for collecting the kinematics and kinetics, respectively. Quality of life will be evaluated with a 36 SF questionnaire and pain intensity will be evaluated using a visual scale. The Intervention will be a medical insole with a 6-degree of heel and sole wedge on the lateral side for the affected side, ethyl vinyl acetate with a shore of 70 in the lateral half and shore of 20 in the medial half, supporting both the longitudinal and the transverse arches and embedded in a neoprene sock with a subtalar strap. The data will be collected at three conditions: bare feet, wearing shoes without medical insoles, and the use of insoles embedded in neoprene socks at 8-12 AM. Each test will repeat six times, so each person experiences a total of 36 tests. People will walk between 3 to 6 times with two minutes of rest between efforts.
Participants/Inclusion and exclusion criteria
Unilateral osteoarthritis of the Medial compartment of the knee, confirmed by a physician expert in orthopedics or physical medicine. The intervention has no adverse effect on the participants
Intervention groups
Two density Insoles with Lateral Wedge Embedded inside a Novel Neoprene Sock
Main outcome variables
pain, quality of life, ground reaction force, step length, step time, velocity, cadence, double limb support duration, step width,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230528058315N1
Registration date: 2023-08-12, 1402/05/21
Registration timing: prospective

Last update: 2023-08-12, 1402/05/21
Update count: 0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Nahid Tafti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1633
Email address
n.tafti@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating The immediate Effect of Using Two density Insoles with Lateral Wedge Embedded inside a Novel Neoprene Sock on Pain, Quality of Life, and Biomechanical Parameters of the Knee Joint During walking in the Elderly with Medial Compartment Knee Osteoarthritis
Public title
Evaluating The Effect of Using Two density Insoles with Lateral Wedge in the Elderly with Medial Compartment Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
unilateral osteoarthritis of the medial compartment of the knee joint
Exclusion criteria:
Any symptom caused due to the negative effect of the intervention receiving any simultaneous treatment in the form of intra-articular injection or physical therapy the presence of any accompanying injury such as problems in the wrist and hip joints low back pain rheumatoid arthritis
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Hamadan university of medical sciences
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517754175
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.UMSHA.REC.1402.081

Health conditions studied

1

Description of health condition studied
osteoarthritis of the medial compartment of the knee joint
ICD-10 code
M19.90
ICD-10 code description
Unspecified osteoarthritis, unspecified site

Primary outcomes

1

Description
pain
Timepoint
before and immediately after intervention
Method of measurement
visual analogue scale

2

Description
Quality of life
Timepoint
before and immediately after intervention
Method of measurement
Persian version of S-F36 questionnaire

3

Description
Spatiotemporal parameters of walking
Timepoint
before and immediately after intervention
Method of measurement
Qualysis motion capture system

4

Description
Ground Reaction Force
Timepoint
before and immediately after intervention
Method of measurement
Kistler Force platform

Secondary outcomes

empty

Intervention groups

1

Description
A pair of laced neoprene socks equipped with medical insoles will be provided to people with one-sided osteoarthritis of the internal compartment of the knee joint. The neoprene sock encompasses a medical insole and a strap is sewn to its upper to stabilize the subtalar joint, which prevents heel eversion and provides ankle stability. The insole will be made of ethyl vinyl acetate foam with two different densities, the lateral part with a hardness of A:70 and the medial with a hardness of A:20. The lateral half of the insole will also have a 6 mm heel and sole wedge. The design and fabrication of medical insoles will be done with the aid of a computer in the specialized foot clinic, Shahid Mobasher Rehabilitation Clinic, Hamadan. Data will be collected after 10 minutes of walking with the sock including the medical insole and the patient's accommodation achievement.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tavana Physiotherapy center
Full name of responsible person
Akbar Sufizadeh
Street address
No. 6, Shahid Gheiratian Ave, Pastor Ave, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517833131
Phone
+98 918 546 4955
Email
Sufizadeh.Aakbar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
Shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Tafti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and prosthetics
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
3716846419
Phone
+98 81 3838 1633
Fax
Email
N.Tafti@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Tafti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and prosthetics
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517754175
Phone
+98 81 3838 1633
Fax
Email
N.Tafti@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Tafti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
3716846419
Phone
38381571
Email
Na.Tafti@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to intellectual property rights, the data will be reported only in the form of published papers
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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