Knee OsteoarthritisNCT07093229
Knee Osteoarthritis in Elderly People - Gait Analysis
A study testing 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 and Gait training in people with Knee Osteoarthritis and Physical Performance Parameters, run by Diana Kamal at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Physical Performance Parameters, Ultrasound
- What is being tested?
- 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 and Gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRomania
- Study dates
- 2 Jun 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gait Analysis as a Measure of Physical Performance in Managing Bilateral Knee Osteoarthritis in Elderly People
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.
- Being tested
- 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
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound exam of quadriceps muscles (left/right) and gait analysisOther
Also called Electrotherapy measures, Kinetic program, Gait analysis, Functional assessment
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 dailyOther
Also called Gait training
The gait training is the distinguish aspect in rehabilitation program. Usually, KOA training include only kinetic measures, without gait control training
Gait trainingOther
This type of special kinetic training includes Frenkel exercises for lower limb muscles and virtual / mirror exercises for different types of gait
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Physical performance - gait analysis
Six Minutes Walking Test (6 MWT) - "walking distance" (meters) and "average cadence" (steps/minute).
Measured: 3 months
Secondary outcomes (1)
Functional status - quality of life
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start2 Jun 2025
- Primary completion10 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diana Kamal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diana Kamal, Filantropia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093229
- Sponsor's protocol ID
- Filantropia Hospital
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis as a Measure of Physical Performance in Managing Bilateral Knee Osteoarthritis in Elderly People
- ClinicalTrials.gov ID
- NCT07093229
- Acronym / sponsor ID
- Filantropia Hospital
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Diana KamalUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | 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 trainingExperimental: 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. |
| Control Group | Active comparator | 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 dailyActive 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound exam of quadriceps muscles (left/right) and gait analysisAlso: Electrotherapy measures, Kinetic program, Gait analysis, Functional assessmentUltrasound 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 | 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 dailyAlso: Gait trainingThe gait training is the distinguish aspect in rehabilitation program. Usually, KOA training include only kinetic measures, without gait control training | Other | Control Group, Study Group |
| Gait trainingThis type of special kinetic training includes Frenkel exercises for lower limb muscles and virtual / mirror exercises for different types of gait | Other | Study Group |
Primary outcome
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.
Physical performance - gait analysis
Time frame: 3 months
Six Minutes Walking Test (6 MWT) - "walking distance" (meters) and "average cadence" (steps/minute).
1 secondary outcome
Functional status - quality of life
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Gait training in people with Knee Osteoarthritis and Physical Performance Parameters, run by Diana Kamal at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical performance - gait analysis (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.