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Status unknownNCT03783806PCHOAIUpdated Dec 24, 2018

Postural Control in Degenerative and Inflammatory Diseases of the Hip

An observational study in Hip Osteoarthritis and Hip Arthritis, sponsored by Szeged University. Status unknown at 1 site in Hungary. Per ClinicalTrials.gov, last updated 2018-12-24.

Sponsored by Szeged University · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
90
Sex
All
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Study 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 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).

02

Conditions studied

  • Hip Osteoarthritis
  • Hip Arthritis

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Keywords

  • hip, postural control, degenerative, inflammation
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In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's planned enrollment of 90 is below the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Szeged University is the lead sponsor of 53 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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,
  • endocrine,
  • cerebrovascular disease,
  • Parkinson's syndrome,
  • epilepsy,
  • polyneuropathy,
  • neuromuscular disorder,
  • cardiovascular disease without medication,
  • atherosclerosis of the lower extremities
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Osteoarthrosis (OA)

    Patients with primary osteoarthrosis, waiting for a total hip replacement. Determination of functional status, posturography measurements, postural tests.

    Diagnostic Test: Posturography measurements

  • Rheumatoid arthritis (RA)

    Patients with rheumatoid arthritis affecting hip joint. Determination of functional status, posturography measurements, postural tests.

    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.

    Diagnostic Test: Posturography measurements

Interventions

  • Diagnostic testPosturography measurements

    Determination of functional status, Posturography measurements, postural tests

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 hour

  2. 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.

    Time frame: 1 hour

  3. 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.

    Time frame: 1 hour

  4. 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.

    Time frame: 1 hour

  5. 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.

    Time frame: 1 hour

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Study locations

1 of 1 sites recruiting
  • University of Szeged, Faculty of Health and Social Studies, Department of Physiotherapy
    Szeged, Csongrad 6726, Hungary
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03783806
Lead sponsor
Szeged University
Responsible party
Edit Nagy (PhD, Head of Unit, Szeged University) — Principal investigator
First posted
Dec 21, 2018
Start date
Jan 1, 2015
Primary completion
Dec 18, 2018
Completion
Dec 18, 2018 (estimated)
Last update
Dec 24, 2018

Study contacts

Edit Nagy, PhD
Contact
editsnagy@gmail.com
+36703824421
Regina Finta
Contact
fintaregina@etszk.u-szeged.hu
+36708844435

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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