Knee Osteoarthritis in Elderly People - Gait Analysis

NCT07093229 | Enrolling By Invitation

• 1 other identifier: Filantropia Hospital
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Physical Performance Parameters; Ultrasound; Quality of Life (QOL)

Outcome Measures

Primary Outcomes (2)

• Physical performance - gait analysis

  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.

  3 months

• Physical performance - gait analysis

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

  3 months

Secondary Outcomes (1)

• Functional status - quality of life

  3 months

Other Outcomes (2)

• Quadriceps muscle index

  3 months

• Physical performance - gait analysis. Symmetry index

  3 months

Study Arms (2)

Study Group

EXPERIMENTAL

Experimental: Study Group. Elderly participants diagnosed with bilateral KOA will receive complete rehabilitation program (10 sessions of electrotherapy measures - transcutaneous nerve stimulation, ultrasound and low intensity laser treatment; 6 weeks of kinetic measures and gait training). Previous, all participants will be complete gait clinical, ultrasound and functional assess.

Other: Ultrasound exam of quadriceps muscles (left/right) and gait analysis; 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; Other: Gait training

Control Group

ACTIVE COMPARATOR

Active Comparator: Control Group Control Group will receive only 10 sessions of electrotherapy (transcutaneous nerve stimulation, ultrasound and low intensity laser treatment) and 6 weeks of kinetic measures, without gait control training. Previous, all participants will be complete clinical gait, ultrasound and functional assess.

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

Interventions

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).

Also known as: Electrotherapy measures, Kinetic program, Gait analysis, Functional assessment

Control Group; Study Group

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

Also known as: Gait training

Control Group; Study Group

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

Study Group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diana Kamal: lead

Study Sites (1)

Diana Kamal

Craiova, 1100, Romania

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Gait Analysis; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 30, 2025
• Study Start: June 2, 2025
• Primary Completion: September 10, 2025
• Study Completion: October 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

RO (1)