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NCT Number: NCT07093229

Knee Osteoarthritis in Elderly People - Gait Analysis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Physical Performance Parameters Quality of Life (QOL) Rheumatic Diseases Ultrasound

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diana Kamal

Craiova, 1100, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound exam of quadriceps muscles (left/right) and gait analysis

Other

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 analysis with wireless system - BTS G-WALK; the investigators consider four gait parameters: Timed Up-and-Go (TUG) test, Symmetry index, Six Minutes Walking Test (6 MWT), and Walk cadence or average cadence (steps/min).

Other names: Electrotherapy measures, Kinetic program, Gait analysis, Functional assessment

Electrotherapy measures: transcutaneous nerve stimulation, ultrasound and low intensity laser; each one daily , applied on both lower limbs, for 10 days. Kinetic measures daily

Other

The gait training is the distinguish aspect in rehabilitation program. Usually, KOA training include only kinetic measures, without gait control training

Other names: Gait training

Gait Training

Other

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

Primary outcomes

  1. Physical performance - gait analysis

    Time frame: 3 months

    Timed Up-and-Go (TUG) test (seconds) - participants stood up from an armed chair, walked at a safe and comfortable pace to a line 3 m away, crossed the line, turned, and returned to a sitting position in the chair; none of the patients used a walking aid and the time to complete the task was recorded.

  2. Physical performance - gait analysis

    Time frame: 3 months

    Six Minutes Walking Test (6 MWT) - "walking distance" (meters) and "average cadence" (steps/minute).

Secondary outcomes

  1. Functional status - quality of life

    Time frame: 3 months

    WOMAC scale contains 24 specific questions divided into three domains: pain (P-WOMAC; 5 items), stiffness (S-WOMAC; 2 items) and physical function (PF-WOMAC; 17 items). The score of each question ranges from 0 to 4. The 0 score is equivalent to maximal functional status and high scores 96 indicates a minimum status, with high disruption in day to day tasks.

Other outcomes

  1. Quadriceps muscle index

    Time frame: 3 months

    In ultrasound exam, after establishing the midway point between the tip of the greater trochanter and the lateral joint line of the knee, the investigators identify the muscle tissue; the thickness of the quadriceps muscle (in centimeters) is established by measuring the space between the cortex of the femur and therefore the most superficial muscular fascia. Quadriceps muscle index is calculated as sum of both quadriceps muscle thickness Right and Left centimeters/ participant square height (square meters). Participant is exam with the knee extended.

  2. Physical performance - gait analysis. Symmetry index

    Time frame: 3 months

    Symmetry index - for the participant's ability to have an identical model of acceleration and deceleration of their center of mass regardless of the side of the gait cycle

Sponsors and collaborators

Lead sponsor

Diana Kamal

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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