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Investigation the effect of valgus unloading knee brace on gait harmonic ratio in patients with medial compartment knee osteoarthritis

Investigation the effect of valgus unloading knee brace on gait harmonic ratio in patients with medial compartment knee osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20131225015932N15
Enrollment
20
Registered
2019-11-23
Start date
2019-11-24
Completion date
Unknown
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis. Osteoarthritis of knee

Interventions

Intervention 1: 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 simi

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).;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.;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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Motealleh

Shiraz University of Medical Sciences

Motealleh@Sums.ac.ir+98 71 3627 1551

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026