Knee Osteoarthritis in Elderly People - Gait Analysis

NCT ID: NCT07093229

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-02
• Study Completion Date: 2025-10-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study Group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

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

Intervention Type: OTHER

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

Gait training

Intervention Type: OTHER

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

Control Group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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).

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

Intervention Type: OTHER

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

Interventions

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 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).

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Electrotherapy measures; Kinetic program; Gait analysis; Functional assessment; Gait training

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diana Kamal

OTHER

Sponsor Role: lead

Responsible Party

Diana Kamal

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Diana Kamal

Craiova, , Romania

Countries

Romania

Other Identifiers

Filantropia Hospital

Identifier Type: -

Identifier Source: org_study_id