Hip OsteoarthritisPCHOAINCT03783806
Postural Control in Degenerative and Inflammatory Diseases of the Hip
An observational study of Hip Osteoarthritis and Hip Arthritis, run by Szeged University at 1 site in Hungary.
Trial summary
Patients with primary hip osteoarthritis (OA group) and patients with inflammatory hip disease (RA group) and healthy subjects (control group) are enrolled in the study. The aim of our study is to determine the postural control in patients suffering from OA and RA of the hip joint during different conditions, i.e., on… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthritis
- What is being tested?
- Posturography measurements
- How many people
- 90 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2015to 18 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with primary hip osteoarthritis (OA group), patients with inflammatory hip disease (RA group) and healthy subjects (control group) are enrolled in the study. All subjects were independent and capable of self-care and daily household tasks.
Who may be able to join
- C-reactive protein and Westergreen values had to be under the upper level of the normal values.
- Patients should have unilateral hip pain on most of the days for several months
- Controls should have no hip pain or functional impairment in the hip joint or any other joint of the lower extremities.
Who cannot join
- history of trauma to the hip joint or in the pelvic region,
- previous hip fracture or hip surgery,
- hip joint infection and congenital or developmental diseases
- any complaints in the other joints of the lower limbs
- any disease that could worsen their physical or balance parameters
- cancer,
Show all 14Show fewer
- endocrine,
- cerebrovascular disease,
- Parkinson's syndrome,
- epilepsy,
- polyneuropathy,
- neuromuscular disorder,
- cardiovascular disease without medication,
- atherosclerosis of the lower extremities
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
University of Szeged, Faculty of Health and Social Studies, Department of Physiotherapy
Szeged, Csongrád megye, 6726
Edit Nagy, PhD, +36703824421, editsnagy@gmail.com
About this study
Patients with primary hip osteoarthritis (OA group) and patients with inflammatory hip disease (RA group) and healthy subjects (control group) are enrolled in the study. The aim of our study is to determine the postural control in patients suffering from OA and RA of the hip joint during different conditions, i.e., on both stable and compliant surfaces with opened or closed eyes to determine the possible differences between these two diseases in this respect.
Read the detailed description
Determination of functional status, using the following outcome measures: Harris Hip Score, the Functional status of the hip joint is rated with the Harris Hip Score (HHS), Visual Analogue Scale, Western Ontario and McMaster Universities Osteoarthritis Index, Timed Up \& Go test.
Posturography measurements, Postural control tests
The Clinical Test of Sensory Interaction on Balance (CTSIB) uses different conditions to test how people adapt to changing sensory conditions during the maintenance of stance. We used the modified CTSIB by NeuroCom to perform the test on a computerized force plate to measure the body sway. Static postural stability [displacement of Centre of Pressure (CoP)] was measured during standing on a single force platform (Stabilometer, ZWE-PII) for 20-s periods in a quiet room. Signals were amplified and sampled at 16 Hz via an analogue-to-digital converter. Subjects stood barefoot on the platform, with the feet positioned side by side and arms hanging freely at their side. Toe-out was positioned to subjects' comfort. The CoP excursions along antero-posterior (AP) and medio-lateral (ML) axes were performed both on firm (the stable surface of the platform) and foam surfaces [an Airex Balance Pad (dimensions: 50 cm length x 41 cm width x 6 cm height) placed on the platform], always starting with standing on the stable surface. In each condition, subjects had to stand first with the eyes open (EO), when subjects had to look at a target fixed at eye level at a distance of approximately 1 m, and then measurements were also performed with closed eyes (EC).
- Conditions
- Hip Osteoarthritis, Hip Arthritis
- Being tested
- Posturography measurements
- Keywords
- hip, postural control, degenerative, inflammation
- Medical subject headings
- Osteoarthritis, Hip, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posturography measurementsDiagnostic test
Determination of functional status, Posturography measurements, postural tests
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthrosis (OA) | Patients with primary osteoarthrosis, waiting for a total hip replacement. Determination of functional status, posturography measurements, postural tests. Receives: Diagnostic Test: Posturography measurements | |
| Rheumatoid arthritis (RA) | Patients with rheumatoid arthritis affecting hip joint. Determination of functional status, posturography measurements, postural tests. Receives: Diagnostic Test: Posturography measurements | |
| Control (C) | The healthy reference group was matched with the patient groups for age, gender and body mass index (BMI). Determination of functional status, posturography measurements, postural tests. Receives: Diagnostic Test: Posturography measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS)
The score has a maximum at 100 points (best possible function), covering pain (part I, 1 item, 0-44 points), function and activities (part II, 7 items, 0-47 points) and range of motion and absence of deformity (part III, 3 items, 0-9 points). [Grading: <70 poor, 70-79 fair, 80-89 good, 90-100 excellent
Measured: 1 hour
Visual Analogue Scale
Hip pain (average pain on movement over the previous 72 hours) is assessed by using a Visual Analogue Scale (VAS) (the range of the scale: 0-100 mm; where the subjects subjectively judge the actual level of pain between the minimum and maximum range. The meaning of the end-points: minimum: no pain- maximum: unbearable pain). The lower values represent better outcome.
Measured: 1 hour
Western Ontario and McMaster Universities Osteoarthritis Index
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to assess pain (WOMAC A, 5 items), joint stiffness (WOMAC B, 2 items) and disability (WOMAC C, 17 items) by using visual analogue scales. Lower scores indicated less pain, less stiffness or less disability.
Measured: 1 hour
Timed Up & Go test
To assess the functional mobility of the subjects, we applied the Timed Up \& Go (TUG) test. During the testing procedure, subjects were timed (recorded in seconds) for standing up from a chair (45 cm), walking 3 m, passing around an object and then returning to sitting position in the chair. The subjects were instructed to walk as quickly as possible but not to run. The subjects had three trials with 1 min pause between each trial; the trials were recorded in seconds.
Measured: 1 hour
Posturography measurements
The Clinical Test of Sensory Interaction on Balance (CTSIB) uses different conditions to test how people adapt to changing sensory conditions during the maintenance of stance. We used the modified CTSIB by NeuroCom to perform the test on a computerized force plate to measure the body sway. Static postural stability [displacement of Centre of Pressure (CoP)] was measured during standing on a single force platform (Stabilometer, ZWE-PII) for 20-s periods in a quiet room.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start1 Jan 2015
- Primary completion18 Dec 2018
- Study completion18 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edit Nagy, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783806
- Sponsor's protocol ID
- PCHOAI
- Acronym
- PCHOAI
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- 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 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Control in Degenerative and Inflammatory Diseases of the Hip
- ClinicalTrials.gov ID
- NCT03783806
- Acronym / sponsor ID
- PCHOAI / PCHOAI
- Conditions
- Hip Osteoarthritis, Hip Arthritis
- Keywords
- hip, postural control, degenerative, inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (estimated)
- First posted
- 21 Dec 2018 (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.
Patients with primary hip osteoarthritis (OA group) and patients with inflammatory hip disease (RA group) and healthy subjects (control group) are enrolled in the study. The aim of our study is to determine the postural control in patients suffering from OA and RA of the hip joint during different conditions, i.e., on both stable and compliant surfaces with opened or closed eyes to determine the possible differences between these two diseases in this respect.
Detailed description
Determination of functional status, using the following outcome measures: Harris Hip Score, the Functional status of the hip joint is rated with the Harris Hip Score (HHS), Visual Analogue Scale, Western Ontario and McMaster Universities Osteoarthritis Index, Timed Up \& Go test.
Posturography measurements, Postural control tests
The Clinical Test of Sensory Interaction on Balance (CTSIB) uses different conditions to test how people adapt to changing sensory conditions during the maintenance of stance. We used the modified CTSIB by NeuroCom to perform the test on a computerized force plate to measure the body sway. Static postural stability [displacement of Centre of Pressure (CoP)] was measured during standing on a single force platform (Stabilometer, ZWE-PII) for 20-s periods in a quiet room. Signals were amplified and sampled at 16 Hz via an analogue-to-digital converter. Subjects stood barefoot on the platform, with the feet positioned side by side and arms hanging freely at their side. Toe-out was positioned to subjects' comfort. The CoP excursions along antero-posterior (AP) and medio-lateral (ML) axes were performed both on firm (the stable surface of the platform) and foam surfaces [an Airex Balance Pad (dimensions: 50 cm length x 41 cm width x 6 cm height) placed on the platform], always starting with standing on the stable surface. In each condition, subjects had to stand first with the eyes open (EO), when subjects had to look at a target fixed at eye level at a distance of approximately 1 m, and then measurements were also performed with closed eyes (EC).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteoarthrosis (OA) | – | Diagnostic Test: Posturography measurementsPatients with primary osteoarthrosis, waiting for a total hip replacement. Determination of functional status, posturography measurements, postural tests. |
| Rheumatoid arthritis (RA) | – | Diagnostic Test: Posturography measurementsPatients with rheumatoid arthritis affecting hip joint. Determination of functional status, posturography measurements, postural tests. |
| Control (C) | – | Diagnostic Test: Posturography measurementsThe healthy reference group was matched with the patient groups for age, gender and body mass index (BMI). Determination of functional status, posturography measurements, postural tests. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary hip osteoarthritis (OA group), patients with inflammatory hip disease (RA group) and healthy subjects (control group) are enrolled in the study. All subjects were independent and capable of self-care and daily household tasks.
Key inclusion criteria (3 listed)
- C-reactive protein and Westergreen values had to be under the upper level of the normal values.
- Patients should have unilateral hip pain on most of the days for several months
- Controls should have no hip pain or functional impairment in the hip joint or any other joint of the lower extremities.
Key exclusion criteria (14 listed)
- history of trauma to the hip joint or in the pelvic region,
- previous hip fracture or hip surgery,
- hip joint infection and congenital or developmental diseases
- any complaints in the other joints of the lower limbs
- any disease that could worsen their physical or balance parameters
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 |
|---|---|---|
| Posturography measurementsDetermination of functional status, Posturography measurements, postural tests | Diagnostic test | Control (C), Osteoarthrosis (OA), Rheumatoid arthritis (RA) |
Primary outcome
Harris Hip Score (HHS)
Time frame: 1 hour
The score has a maximum at 100 points (best possible function), covering pain (part I, 1 item, 0-44 points), function and activities (part II, 7 items, 0-47 points) and range of motion and absence of deformity (part III, 3 items, 0-9 points). [Grading: <70 poor, 70-79 fair, 80-89 good, 90-100 excellent
Visual Analogue Scale
Time frame: 1 hour
Hip pain (average pain on movement over the previous 72 hours) is assessed by using a Visual Analogue Scale (VAS) (the range of the scale: 0-100 mm; where the subjects subjectively judge the actual level of pain between the minimum and maximum range. The meaning of the end-points: minimum: no pain- maximum: unbearable pain). The lower values represent better outcome.
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 1 hour
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to assess pain (WOMAC A, 5 items), joint stiffness (WOMAC B, 2 items) and disability (WOMAC C, 17 items) by using visual analogue scales. Lower scores indicated less pain, less stiffness or less disability.
Timed Up & Go test
Time frame: 1 hour
To assess the functional mobility of the subjects, we applied the Timed Up \& Go (TUG) test. During the testing procedure, subjects were timed (recorded in seconds) for standing up from a chair (45 cm), walking 3 m, passing around an object and then returning to sitting position in the chair. The subjects were instructed to walk as quickly as possible but not to run. The subjects had three trials with 1 min pause between each trial; the trials were recorded in seconds.
Posturography measurements
Time frame: 1 hour
The Clinical Test of Sensory Interaction on Balance (CTSIB) uses different conditions to test how people adapt to changing sensory conditions during the maintenance of stance. We used the modified CTSIB by NeuroCom to perform the test on a computerized force plate to measure the body sway. Static postural stability [displacement of Centre of Pressure (CoP)] was measured during standing on a single force platform (Stabilometer, ZWE-PII) for 20-s periods in a quiet room.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis and Hip Arthritis, run by Szeged University at 1 site in Hungary.
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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 24 Dec 2018. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edit Nagy, PhD (+36703824421, editsnagy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (HHS) (time frame: 1 hour). The study lists 5 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 24 Dec 2018.