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

Primary Purpose

Arthroplasty Complications, Physical Disability, Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty Complications focused on measuring osteoarthritis, hip, total hip arthroplasty, balance training, function, assessment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional rehabilitation group

conventional rehabilitation + balance training group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
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.

Secondary Outcome Measures

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".
Range of motion
Hip extension, hipflexion, hip abduction and hip adduction was measured with goniometer.
Muscle strength
Maximal isometric muscle strength was measured with a handheld dynamometer (HHD) (Lafayette Instrument Company).

Full Information

First Posted
June 10, 2020
Last Updated
June 15, 2020
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04433962
Brief Title
Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty
Official Title
Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
October 20, 2015 (Actual)
Study Completion Date
December 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty Complications, Physical Disability, Osteoarthritis, Hip
Keywords
osteoarthritis, hip, total hip arthroplasty, balance training, function, assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional rehabilitation group
Arm Type
Active Comparator
Arm Description
the conventional rehabilitation group completed hip joint range of motion and muscle strengthening exercises
Arm Title
conventional rehabilitation + balance training group
Arm Type
Experimental
Arm Description
The conventional rehabilitation + balance training group completed hip joint range of motion and muscle strengthening exercises and 12 balance exercises.
Intervention Type
Other
Intervention Name(s)
Exercise training
Other Intervention Name(s)
conventional rehabilitation, conventional rehabilitation and balance training
Primary Outcome Measure Information:
Title
single leg test
Description
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
Title
Tetrax Balance Assessment
Description
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
Title
Sit to stand test
Description
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
Title
50 feet walk test
Description
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
Title
Harris hip score
Description
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
Title
Lower extremity function scale
Description
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 Outcome Measure Information:
Title
Pain assessment
Description
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
Title
Range of motion
Description
Hip extension, hipflexion, hip abduction and hip adduction was measured with goniometer.
Time Frame
Pre-op to post-op 26. week
Title
Muscle strength
Description
Maximal isometric muscle strength was measured with a handheld dynamometer (HHD) (Lafayette Instrument Company).
Time Frame
Pre-op to post-op 26. week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuray Elibol, PhD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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