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Enrolling by invitation NCT07093229

Knee Osteoarthritis in Elderly People - Gait Analysis

No phase Interventional Knee Osteoarthritis Physical Performance Parameters Ultrasound Quality of Life (QOL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound exam of quadriceps muscles (left/right) and gait analysis, Electrotherapy measures: transcutaneous nerve stimulation, ultrasound and low intensity laser; each one daily , applied on both lower limbs, for 10 days. Kinetic measures daily, Gait training.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Physical Performance Parameters, Ultrasound, Quality of Life (QOL). Basic parameters: 65 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other 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
  • Other 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
  • Other Gait training
    This type of special kinetic training includes Frenkel exercises for lower limb muscles and virtual / mirror exercises for different types of gait

Primary outcome measures

  • Physical performance - gait analysis [Time frame: 3 months]
  • Physical performance - gait analysis [Time frame: 3 months]
Secondary outcome measures (1)
  • Functional status - quality of life [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Romania · 1 center
  • Diana Kamal — Craiova

Identifiers

NCT: NCT07093229 · Filantropia Hospital

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗