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CompletedNCT04433962Updated Jun 16, 2020

Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty

An interventional study of Exercise training in Arthroplasty Complications, Physical Disability and Osteoarthritis, Hip, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 9 months after the study started (first participant enrolled Sep 2014, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the effects of balance training in patients with THA until 26 weeks postoperatively. Thirty-two patients with hip osteoarthritis who were candidates for THA were recruited to the study. Sixteen patients with THA completed the study protocol and the patients were randomized into 2 groups: conventional rehabilitation (CR, n=8) or conventional rehabilitation plus balance training (CR + BT, n=8) groups. The patients were evaluated by hand-held dynamometer, single leg stance test (SLST), Tetrax balance system, Harris hip score, lower extremity function scale, 5 times sit-to-stand test and 50 foot timed walk test preoperatively and in the 8th, 14th and 26th weeks postoperatively.

02

Conditions studied

  • Arthroplasty Complications
  • Physical Disability
  • Osteoarthritis, Hip

Keywords

  • osteoarthritis
  • hip
  • total hip arthroplasty
  • balance training
  • function
  • assessment
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 32 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Total hip arthroplasty due to osteoarthritis
  • First time hip surgery/prothesis
  • no involvement in any exercise program in the past 12 months

Exclusion criteria

Exclusion Criteria:

  • THA due to hip fracture,
  • revision hip prothesis,
  • arthritis in other joints limited function
  • neurologic problems that limited function and balance,
  • body mass index greater than 40 kg/m2.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    conventional rehabilitation group

    the conventional rehabilitation group completed hip joint range of motion and muscle strengthening exercises

    Other: Exercise training

  • Experimental
    conventional rehabilitation + balance training group

    The conventional rehabilitation + balance training group completed hip joint range of motion and muscle strengthening exercises and 12 balance exercises.

    Other: Exercise training

Interventions

  • OtherExercise training

    Also known as: conventional rehabilitation, conventional rehabilitation and balance training

06

What researchers measure

Primary outcomes

  1. single leg test

    Patients were tested first with eyes opened and then with eyes closed; they were asked to stand on either their left or right leg and tried to keep their legs from touching and to maintain single-leg stance for as long as possible. The test and time began once the foot was lifted off the floor, and ended when placing the lifted foot on the floor or with arm movements. The test was terminated following a maximum of 45 s, and each leg was tested three times with eyes opened and eyes closed and the best of the three trials were recorded

    Time frame: Pre-op to post-op 26. week

  2. Tetrax Balance Assessment

    Tetrax Balance Assessment System (Sunlight Medical Ltd.Ramat Gan, Israel); is a valid, reliable and objective method to evaluate balance and fall risk. The system obtains data by using 4 different platforms which measure vertical pressure fluctuations arising from two heels and two fingertips. Patients were instructed an immobile posture for 32 s for each of the eight sensory conditions.The fall risks of the patients were calculated as percentage (%) by a posturographic program considering the oscillation rates. A value between 0% and 36% is judged as mild risk; a value between 37% and 58%, as moderate risk; and between 59% and 100%, as high risk. The higher score is showed the greater falling risk

    Time frame: Pre-op to post-op 26. week

  3. Sit to stand test

    STS; is an objective functional measure of strength correlating with ambulatory independence. Sit-to-stand (such as the 5 STS) activities are recommended as the minimal core set of performance-based outcome measures in OA research and clinical practice \[21\]. Patients sit on a height adjustable chair such that a 90⁰ angle is formed when the femur is horizontal and tibia vertical with their feet shoulder width apart and their arms crossed against their chest. Patients are timed as they 5 times stand up from chair and sit down again without using their hand, time was recorded as second

    Time frame: Pre-op to post-op 26. week

  4. 50 feet walk test

    50 FWT; is a reliable measurement method and commonly used in studies of exercise based OA. All patients are asked to walk as quickly as possible in 50 feet length distance. The physiotherapist counted number of steps and as soon as the patient finished to walking 50 feet length distance and the time was recorded as seconds

    Time frame: Pre-op to post-op 26. week

  5. Harris hip score

    Many different hip scoring scales are used in assessment of THA's results \[23\]. HHS is a joint specific outcome measurements and the most frequently used in assessment of THA patients. It has been used in a number of studies over the years and has been shown to have high validity and reliability \[23,24\]. HHS was recorded, a score commonly used in this context, which contains questions about pain, function, absence of deformity, and range-of-motion. The best possible score is 100 points

    Time frame: Pre-op to post-op 26. week

  6. Lower extremity function scale

    is a region specific measure, was conceived to assess the lower extremity functional status of patients and the reliability estimates have been high when investigated in the THA and TKA population. The LEFS is composed of 20 items each scored on a 5 point adjectival scale with '0' extreme difficulty or unable to perform the activity and '4' no difficulty. The items are summed to produce a total LEFS score, which can vary from 0 to 80.

    Time frame: Pre-op to post-op 26. week

Secondary outcomes

  1. Pain assessment

    Visual analog scale was used to determine to degree of pain. The patient was asked to choose a number 0 and 10 on a chart. 0 indicates "no pain" and 10 indicates "very severe pain".

    Time frame: Pre-op to post-op 26. week

  2. Range of motion

    Hip extension, hipflexion, hip abduction and hip adduction was measured with goniometer.

    Time frame: Pre-op to post-op 26. week

  3. Muscle strength

    Maximal isometric muscle strength was measured with a handheld dynamometer (HHD) (Lafayette Instrument Company).

    Time frame: Pre-op to post-op 26. week

07

Study locations

1 site
  • Dokuz Eylul University
    Izmir, Bornova 35340, Turkey
08

References and documents

Individual participant data

Plan to share: No

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 Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04433962
Lead sponsor
Ege University
Responsible party
Nuray Elibol (Assistant of Professor, Ege University) — Principal investigator
First posted
Jun 16, 2020
Start date
Sep 1, 2014
Primary completion
Oct 20, 2015
Completion
Dec 25, 2016
Last update
Jun 16, 2020

Study contacts

Nuray Elibol, PhD
principal investigator · Ege University

Oversight

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

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