Knee Osteoarthritis in Elderly People - Gait Analysis

Официальное название

Gait Analysis as a Measure of Physical Performance in Managing Bilateral Knee Osteoarthritis in Elderly People

Обзор

The investigators perform a prospective controlled study and assess gait parameters in bilateral knee osteoarthritis (KOA) elderly patients with wireless system - BTS G-WALK, pre- and post-rehabilitation program. The complete assessment include: ultrasound exam, gait parameters and functional scale. The investigators investigate the real impact of complete rehabilitation program, with gait control, on the physical performance and functional status.

Вмешательства

• Другое Ultrasound exam of quadriceps muscles (left/right) and gait analysis
  Ultrasound exam (initial and after 3 months) - with SonoScape S9Pro; the investigators exam the thickness of the quadriceps muscle group between the superficial fat-muscle interface and the cortex of the femur and calculate the quadriceps muscle index as sum of both muscle thickness RT and LT cm/height2 (m2). The exam is conducted by a qualified sonographer. The examination is carried out on a one-on-one basis in a private setting where only the participant and the sonographer are present. Gait
• Другое Electrotherapy measures: transcutaneous nerve stimulation, ultrasound and low intensity laser; each one daily , applied on both lower limbs, for 10 days. Kinetic measures daily
  The gait training is the distinguish aspect in rehabilitation program. Usually, KOA training include only kinetic measures, without gait control training
• Другое Gait training
  This type of special kinetic training includes Frenkel exercises for lower limb muscles and virtual / mirror exercises for different types of gait

Первичные конечные точки

• Physical performance - gait analysis [Срок оценки: 3 months]
• Physical performance - gait analysis [Срок оценки: 3 months]

Вторичные конечные точки (1)

• Functional status - quality of life [Срок оценки: 3 months]

Критерии участия

Критерии включения

• participants older than 65 years diagnosed with KOA according to ACR criteria, also accepted in our country;
• at least 5 years of disease progression;
• painful knee for a period of 48 hours after physical activity;
• absence of knee injuries at least 6 months before;
• absence of major disturbances in the frontal plane alignment of the knee;
• participants with other co-morbidities, but well controlled, like: arterial hypertension, dyslipidaemia and mellitus diabetes type II; a history of a symptomatic or complicated upper gastro-intestinal ulcer;
• compliance with physical exercise during the healthcare program.

Критерии исключения

• unstable medical conditions preventing the patient from participating in the rehabilitation programs,
• history of knee replacement,
• neurological or any other conditions affecting strength or function of lower limbs.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Румыния · 1 центр

• Diana Kamal — Craiova

Идентификаторы

NCT: NCT07093229 · Filantropia Hospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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