Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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).
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Main outcome variables
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KOOS questionnaire؛ Harmonic ratio؛ Balance (star test)؛ Walking speed and isometric quadriceps strength
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-11-23, 1398/09/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-24, 1398/09/03
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Expected recruitment end date
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2020-02-22, 1398/12/03
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigation the effect of valgus unloading knee brace on gait harmonic ratio in patients with medial compartment knee osteoarthritis
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Public title
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Investigation the effect of valgus unloading knee brace on gait harmonic ratio in patients with medial compartment knee osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 45 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-09, 1398/07/17
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Ethics committee reference number
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IR.SUMS.REHAB.REC.1398.029
Health conditions studied
1
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Description of health condition studied
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Knee osteoarthritis
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Harmonic ratio measured with accelerometer
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Timepoint
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Baseline (before intervention) and one week after intervention (one month intervention)
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Method of measurement
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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
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Description
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Pain and disability measered with KOOS quationniare
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Timepoint
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Baseline (before intervention) and one week after intervention (one month intervention)
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Method of measurement
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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
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Description
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Balance
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Timepoint
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Baseline (before intervention) and one week after intervention (one month intervention)
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Method of measurement
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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
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Description
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Pain meassured with PI-NRS (Pain intensity numeric range scale)
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Timepoint
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Baseline (before intervention) and one week after intervention (one month intervention)
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Method of measurement
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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
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Description
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Isometric strength of quadriceps
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Timepoint
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Baseline (before intervention) and one week after intervention (one month intervention)
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Method of measurement
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Isometric quadriceps muscle strength will be measured using a handheld dynamometer
Intervention groups
1
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Description
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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
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Category
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Rehabilitation
2
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Description
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Control group: During the intervention, the control group performs similar exercises to the intervention group
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Study participants' personal data will be shared after unidentifiable individuals
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When the data will become available and for how long
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The access period begins 6 months after the results are published
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To whom data/document is available
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All academics as well as the public can access this data
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Under which criteria data/document could be used
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The data will be made publicly available for further analysis with a citation
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From where data/document is obtainable
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Dr. Alireza Motaleh, Rehabilitation Sciences school, Shiraz University of Medical Sciences, Chamran Boulevard, Abivardi Ave., Phone 00987136271551, Email Motealleh@sums.ac.ir
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What processes are involved for a request to access data/document
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6 months after the results are published, people will be notified by email or phone
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Comments
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