Postural Control in Degenerative and Inflammatory Diseases of the Hip

NCT03783806 | Unknown

• 1 other identifier: PCHOAI
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Osteoarthritis; Hip Arthritis

Keywords

hip, postural control, degenerative, inflammation

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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.

  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.

  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.

  1 hour

Study Arms (3)

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

Posturography measurements DIAGNOSTIC_TEST

Determination of functional status, Posturography measurements, postural tests

Control (C); Osteoarthrosis (OA); Rheumatoid arthritis (RA)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

University of Szeged, Faculty of Health and Social Studies, Department of Physiotherapy

Szeged, Csongrád megye, 6726, Hungary

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Inflammation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Edit Nagy, PhD

CONTACT

+36703824421; editsnagy@gmail.com

Regina Finta

CONTACT

+36708844435; fintaregina@etszk.u-szeged.hu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Head of Unit

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: January 1, 2015
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

HU (1)