Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
2019-10-23, 1398/08/01
2019-11-24, 1398/09/03
2019-1011-2324 00:00:00
2019-11-21, 1398/08/30
2020-02-22, 1398/12/03
20192020-1102-2122 00:00:00
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Younes Qasemi
Full name of responsible person - Persian: یونس قاسمی
Street address - English: Shiraz, Setad street, Shiraz university of medical sciences
Street address - Persian: شیراز ، خیابان ستاد، دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 71348-14336
Phone: +98 71 3235 7282
Fax:
Email: ghasemiy@sums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Younes Qasemi
Full name of responsible person - Persian: یونس قاسمی
Street address - English: Shiraz university of medical sciences, Setad street, Shiraz
Street address - Persian: شیراز ، خیابان ستاد، دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 71348-14336
Phone: +98 71 3235 7282
Fax:
Email: ghasemiy@sums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Younes Qasemi Full name of responsible person - Persian: یونس قاسمی Street address - English: Shiraz university of medical sciences, Setad street, Shiraz university of medical sciences Street address - Persian: شیراز ، خیابان ستاد، دانشگاه علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 71348-14336 Phone: +98 71 3235 7282 Fax: Email: ghasemiy@sums.ac.ir Web page address:
Protocol summary
Study aim
Investigate the effect of unloading knee valgus brace on improving harmonic ratio as well as balance (star balance test), pain and disability (KOOS questionnaire) and walking speed in patients with unilateral knee osteoarthritis
Design
This study is a clinical trial and parallel and the subjects will randomly divide into control and intervention groups (Brace).
This is a single-blinded study.
Settings and conduct
The study will be conducted in Shiraz university of Rehabilitation Sciences and the study population (n = 20) will be randomly divided into control and intervention groups (Brace). The intervention group will wear brace for 4 weeks and both groups will perform similar exercises during this period.This is a single-blinded study and the evaluator will be unaware of the nature of the individuals in each group
Participants/Inclusion and exclusion criteria
People with unilateral symptomatic knee osteoarthritis aged 45-75 years who are able to walk at least 15 meters without auxiliary equipment, have K&L grade ≥2 and PI-NRS ≥؛ 2 but dont have lower limb fractures ، history of spine and lower limb surgery In the past 6 months and obvious ligament injuries of the lower limbs and chronic low back pain and any soft tissue, neurological or vascular problems and high obesity (over 20% ideal body weight )and systemic or metabolic diseases , stroke, Parkinson's and rheumatologic conditions other than knee osteoarthritis, enter the study
Intervention groups
Intervention group will wear unloading valgus knee brace on the affected side for 4 weeks, 4 hours daily while standing and during daily activities.
Both experimental and control groups will perform similar exercises at home during the study period (one month).
Main outcome variables
KOOS questionnaire؛ Harmonic ratio؛ Balance (star test)؛ Walking speed and isometric quadriceps strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131225015932N15
Registration date:2019-11-23, 1398/09/02
Registration timing:prospective
Last update:2021-11-21, 1400/08/30
Update count:1
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Alireza Motealleh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
motealleh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-24, 1398/09/03
Expected recruitment end date
2020-02-22, 1398/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of valgus unloading knee brace on gait harmonic ratio in patients with medial compartment knee osteoarthritis
Public title
Investigation the effect of valgus unloading knee brace on gait harmonic ratio in patients with medial compartment knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Symptomatic unilateral knee osteoarthritis
Knee medial compartment involvement
Age 45-75 years
Ability to walk at least 15 meters without auxiliary equipment
K&L grade ≥2 (based on knee x-ray most related to one last year)
PI-NRS ≥ 2
Exclusion criteria:
Articular and lower extremity fractures
History of knee and spine and lower extremity surgery in the past 6 months
knee and hip replacement
tibial osteotomy
Any soft, neurological or vascular tissue problems where wearing a brace is harmful for the long term, including varicose veins and skin problems
Obesity enough to make wearing a brace uncomfortable and uneffective (weighing more than 20% of ideal body weight)
Systemic or metabolic diseases including diabetes
Any condition or diseases other than osteoarthritis that affects walking, including stroke and Parkinson's
chronic low back pain
Ligamentous injuries of the lower extremities
Other rheumatologic diseases except knee osteoarthritis
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be divided equally between the intervention and control groups according to the randomized block allocation method.
How to allocate randomly by variable block method:
Considering that there are two treatment modalities (Brace A and Control B) in this study, there will be six different conditions considering quadri blocks:
1-AABB 2-BBAA 3-ABAB 4-BABA 5-ABBA 6-BAAB
Then we create random numbers using the computer. For numbers between 0 to 1/6 compound 1, numbers between 1/6 to 2/6 compound 2, numbers between 2/6 to 3/6 compound 3 and ... will be considered.
Blinding (investigator's opinion)
Single blinded
Blinding description
After selecting the samples, one person (x) performs the evaluations on all subjects . After performing the measurements, another person (y) divides the patients into two groups, and then another person (z) applies the interventions to the patients. At the end of the study period (1 month), patients will be referred one week later and the person who performed the measurement (x) will repeat the measurements on all subjects. It is noteworthy that the measurements will be made without brace. So the person making the measurements will not be aware of the nature of the grouping of people.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Rehabilitation school of Shiraz University of Medical Sciences, Abivardi Ave., Chamran Boulevard
City
shiraz
Province
Fars
Postal code
71345-1733
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.SUMS.REHAB.REC.1398.029
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Harmonic ratio measured with accelerometer
Timepoint
Baseline (before intervention) and one week after intervention (one month intervention)
Method of measurement
Based on studies to calculate the harmonic gait ratio, accelerometer (Biomethrics) will be fitted to the lower lumbar vertebrae(l4-l5) at the lower back. Gait analysis will be performed using an accelerometer in the laboratory environment as individuals walk a 15-meter-long, horizontal path at their usual speed; a heel switch will be connected in the heel area of right foot to define the start of the walking cycle ; the linear acceleration of the trunk will be sampled along the anterior-posterior, medial-lateral, and vertical axes at a frequency of 200 Hz. Signal processing will be performed using matlab software. To calculate the harmonic ratio using fourier transformation, the contents of the in phase accelerated signals (even harmonics) are compared to the contents of out-of-phase signals (odd harmonics)
Secondary outcomes
1
Description
Pain and disability measered with KOOS quationniare
Timepoint
Baseline (before intervention) and one week after intervention (one month intervention)
Method of measurement
KOOS Questionnaire: Knee Injury and Osteoarthritis Outcome Score This questionnaire contains 42 items that assess the patient's opinion on the five dimensions related to the knee and its problems, including: pain (9 questions), other specialized symptoms of illness (7 Questions), daily life performance (17 questions), recreational and sports performance (5 questions), and knee-related quality of life (4 questions).
2
Description
Balance
Timepoint
Baseline (before intervention) and one week after intervention (one month intervention)
Method of measurement
Star Equilibrium Test: To do this test, 8 strip strips with a 45 degree angle are attached to the ground. Evaluation will be done with the bare foot, and the patient will be asked to stand in the center of the star with the leg that is stance positioned and center the arch, while maintaining the balance on the leg in the center, and with the other foot touch the longest distance on any tape
3
Description
Pain meassured with PI-NRS (Pain intensity numeric range scale)
Timepoint
Baseline (before intervention) and one week after intervention (one month intervention)
Method of measurement
An 11-point scale that reports the patient's pain level. The patient is asked to choose a number between 0 and 10 that is most proportional to their pain intensity
4
Description
Isometric strength of quadriceps
Timepoint
Baseline (before intervention) and one week after intervention (one month intervention)
Method of measurement
Isometric quadriceps muscle strength will be measured using a handheld dynamometer
Intervention groups
1
Description
Intervention group: Intervention group wear knee unloading valgus brace for 4 weeks, daily and 4 hours daily while standing and during daily activities and perform exercises which similar to control group. Patients are asked to record hours of use of the brace
Category
Rehabilitation
2
Description
Control group: During the intervention, the control group performs similar exercises to the intervention group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic of rehabilitation school of Shiraz univercity of medical sciences
Full name of responsible person
Mahnaz Daman
Street address
School of Rehabilitation Sciences, Abivardi St., Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Email
Mahnaz_daman@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Qasemi
Street address
Shiraz university of medical sciences, Setad street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Motealleh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Sciences school, Abivardi Ave One , Chamran Boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
Motealleh@Sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Motealleh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Sciences school, Abivardi Ave One , Chamran Boulevard, Shiraz
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study participants' personal data will be shared after unidentifiable individuals
When the data will become available and for how long
The access period begins 6 months after the results are published
To whom data/document is available
All academics as well as the public can access this data
Under which criteria data/document could be used
The data will be made publicly available for further analysis with a citation
From where data/document is obtainable
Dr. Alireza Motaleh, Rehabilitation Sciences school, Shiraz University of Medical Sciences, Chamran Boulevard, Abivardi Ave., Phone 00987136271551, Email Motealleh@sums.ac.ir
What processes are involved for a request to access data/document
6 months after the results are published, people will be notified by email or phone