Postural Control in Degenerative and Inflammatory Diseases of the Hip

Hip Osteoarthritis Clinical Trial

— PCHOAI  

Official title:

Postural Control in Degenerative and Inflammatory Diseases of the Hip

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03783806
• Other study ID #: PCHOAI
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 18, 2018

Study information

• Verified date: December 2018
• Source: Szeged University
• Contact: Edit Nagy, PhD
• Phone: +36703824421
• Email: editsnagy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 both stable and compliant surfaces with opened or closed eyes to determine the possible differences between these two diseases in this respect.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Hip Arthritis
• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Diagnostic Test:
• Posturography measurements
Determination of functional status, Posturography measurements, postural tests

Locations

Country	Name	City	State
Hungary	University of Szeged, Faculty of Health and Social Studies, Department of Physiotherapy	Szeged	Csongrad

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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