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

NCT04433962 | Completed

• 1 other identifier: 2012/22-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty Complications; Physical Disability; Osteoarthritis, Hip

Keywords

osteoarthritis; hip; total hip arthroplasty; balance training; function; assessment

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Pain assessment

  Pre-op to post-op 26. week

• Range of motion

  Pre-op to post-op 26. week

• Muscle strength

  Pre-op to post-op 26. week

Study Arms (2)

conventional rehabilitation group

ACTIVE COMPARATOR

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

Other: Exercise training

conventional rehabilitation + balance training group

EXPERIMENTAL

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

Other: Exercise training

Interventions

Exercise training OTHER

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

conventional rehabilitation + balance training group; conventional rehabilitation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Bornova, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nuray Elibol, PhD

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant of Professor

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: September 1, 2014
• Primary Completion: October 20, 2015
• Study Completion: December 25, 2016
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)