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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip; Physical Disability; Arthroplasty Complications
• Intervention / Treatment: Other: Exercise training

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • Izmir, Bornova, Turkey, 35340
      • Dokuz Eylul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: conventional rehabilitation group; the conventional rehabilitation group completed hip joint range of motion and muscle strengthening exercises	Other: Exercise training; Other Names: conventional rehabilitation; conventional rehabilitation and balance 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; Other Names: conventional rehabilitation; conventional rehabilitation and balance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pre-op to post-op 26. week
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	Pre-op to post-op 26. week
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	Pre-op to post-op 26. week
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	Pre-op to post-op 26. week
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	Pre-op to post-op 26. week
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.	Pre-op to post-op 26. week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	Pre-op to post-op 26. week
Range of motion	Hip extension, hipflexion, hip abduction and hip adduction was measured with goniometer.	Pre-op to post-op 26. week
Muscle strength	Maximal isometric muscle strength was measured with a handheld dynamometer (HHD) (Lafayette Instrument Company).	Pre-op to post-op 26. week

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Nuray Elibol, PhD, Ege University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2014
• Primary Completion (ACTUAL): October 20, 2015
• Study Completion (ACTUAL): December 25, 2016

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: osteoarthritis; total hip arthroplasty; function; balance training; assessment; hip
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 2012/22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No