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The Validity, Reliability and Responsiveness of the Fullerton Advanced Balance Scale in Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03728387
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sevim Öksüz, Eastern Mediterranean University

Brief Summary:
The primary aim of our study is to evaluate the validity and reliability of the Fullerton Advanced Balance (FAB-T) scale in individuals with osteoarthritis. The secondary aim of this study is to evaluate the responsiveness of the FAB-T scale to change in patients with osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Exercise Balance Other: Clinical Pilates Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Validity, Reliability and Responsiveness of the Fullerton Advanced Balance (FAB-T) Scale in Patients With Osteoarthritis
Actual Study Start Date : February 18, 2019
Actual Primary Completion Date : May 18, 2019
Actual Study Completion Date : June 20, 2019

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Arm Intervention/treatment
Experimental: osteoarthritis and clinical pilates exercise
34 volunteer individuals who will be randomly choosen among 84 individuals will be given a 6-week exercise training program. According to this 6 week program, individuals will be admitted to the exercise training program for 45-60 minutes with a physiotherapist for 3 days in a week. The exercise program will consist of a warm-up, a strength training and a cool-down section.
Other: Clinical Pilates Exercise
All evaluations of the individuals included in the study will be done by the physiotherapist.. For the second evaluation the same individuals will be visited by the same physiotherapist at least 7 days after the first evaluation and only the FAB-T scale will be applied. 34 volunteer individuals who will be randomly choosen among 84 individuals will be given a 6-week exercise training program. According to this 6 week program, individuals will be admitted to the exercise training program for 45-60 minutes with a physiotherapist for 3 days in a week. The exercise program will consist of a warm-up, a strength training and a cool-down section. Various exercise methods (clinical pilates exercises) and tools will be utilized to improve balance and mobility. Third assessment of FAB-T will be applied only to individuals participating in the 6-week exercise training program.




Primary Outcome Measures :
  1. Fullerton Advanced Balance Scale (FAB-T): [ Time Frame: Change will be assessed from the baseline at 1 week and 6th week. ]
    It is a test that determines the functional balance state of individuals. The test has 10 parameters. These are: feet adjacent and eyes closed standing, reaching out forward to reach a shoulder-length object, 360 degrees of turning in right and left directions, stepping and passing over a 15.24 cm-long stair, tandem march, standing on one leg, eyes closed staying on the foam, double feet bounce, walking with head turning, reactive postural control. In this scale, which is scored between 0-40, a score between 0 and 4 is given for each item (8).


Secondary Outcome Measures :
  1. Socio-demographic evaluations [ Time Frame: it will be recorded at the beginning ]
    The sociodemographic variables such as age, gender, body mass index (BMI), marital status, education level and occupational status will be recorded. It will also be questioned whether there are problems with the use of auxiliary devices, problems of loss of balance, activities that individual lost balance, whether if they experience falling problems, for how many years they have been experiencing this problem, whether if there is a fall or fall injury.

  2. Berg Balance Test [ Time Frame: First evaluation will be applied on the first day and after 6 weeks. ]
    is a routine test used in daily life, consisting of evaluation of 14 activities, requiring both dynamic and static balance. If the total score is between 0 and 20, there is a high risk of falling, between 21 and 40 there is a moderate risk of falling, between 41-56 there is a low risk of falling(9).

  3. The Timed Up & Go (TUG) Test: [ Time Frame: First evaluation will be applied on the first day and after 6 weeks. ]
    TUG is a frequently used balance test to assess the functional mobility of individuals. It was developed by Podsiadlo and Richardson in 1991. Test measures the speed during many functional maneuvers such as standing up, walking, turning and sitting. In the test, the person is asked to get up from the chair, to walk for 3 meters with his/her own normal speed, to walk back and to sit on the chair and the time is recorded in seconds (sec). A shorter time indicates better balance and mobility. The starting position should be standardized. It is performed 3 times and the average value is recorded (10).

  4. Single Leg Stance Test [ Time Frame: First evaluation will be applied on the first day and after 6 weeks. ]
    1. Single Leg Stance Test on Hard Ground: the patient is asked to flex the knee with eyes open, hands on the hips, feet naked, and the hip in neutral position. The time is started as soon as the foot is removed from the ground and recorded in seconds. The patient is asked to stand on one foot until the arms move or until the foot is dropped on the floor or until the time reaches 60 sec. For each foot, 3 attempts are made and the average time for each foot is recorded. Rest is allowed between attempts.
    2. Single Leg Stance Test on Foam Ground: Eyes open, hands on the hips, feet naked, hip in neutral position on the foam, participant is required to flex a knee. The patient is asked to stand on one foot until the arms move or until the foot is dropped on the floor or until the time reaches 60 sec. For each foot, 3 attempts are made and the average time for each foot is recorded. Rest is allowed between attempts.

  5. Push and Release Test [ Time Frame: First evaluation will be applied on the first day and after 6 weeks. ]
    While the patient is in the standing position with the eyes open, the physiotherapist stands behind the person and places his/her hand on the person's scapula and participant leans backwards to push the hand of the physiotherapist. The physiotherapist flexes the elbows to allow back movement of the body and supports the person's weight with his/her hands. When a person's shoulders and hips are in a fixed position just behind the heels, the physiotherapist suddenly raises participant's hands. Scoring is based on the response of the individual in trying to regain balance. Scoring: 0. = It gains balance independently with 1 step in normal length and width, 1. = Takes two or three small steps backwards, but independently gains equilibrium, 2. = Takes four or more steps backwards, but independently restores balance, 3 . = Takes the step, but need help to prevent he/she from falling, 4. = falls off without taking a step or can't stop without help (13).

  6. 30 Seconds Sit and Stand Up Test [ Time Frame: First evaluation will be applied on the first day and after 6 weeks. ]
    For proximal muscle strength of the lower extremity and endurance, this test is valid and reliable for adults. In his/her starting position, the person sits on an armless armchair with his back straight, arms crossed in front of the chest and feet on the ground. With the starting of the measument, the person takes the sitting position from a full standing position and the exact numbers of standing uıp within 30 seconds are recorded. Less than 10 repetitions in 30 seconds show lower extremity muscle weakness. The test is performed once (14).

  7. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index: [ Time Frame: First evaluation will be applied on the first day and after 6 weeks. ]
    consists of 24 questions and is divided into 3 subgroups. WOMAC subgroups consisted of 5 pain-related questions, 2 stiffness-related questions, 17 physical function-related problems. In WOMAC assessment, each question is between 0-4 points. Subgroups are evaluated among themselves. According to this, the subgroup of pain is 0-20 points, the stiffness / rigidity is 0-8 points and the physical function subgroup is 0-68 points. During the evaluation of pain, the severity of pain in the last 24 hours is questioned. For stiffness / rigidity sub-parameters, first; the feeling of stiffness is defined and the joint stiffness felt within the last 24 hours in the evaluated joint is questioned. For physical function score, 17 activities that is being challenging for the participant due to arthralgia in the joint is being questioned.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals diagnosed with knee osteoarthritis II-III level according to the results of radiological evaluation by Kellgren and Lawrence
  • Individuals aged between 40 and 65 years
  • Individuals who have pain in his/her either of the knees in 3 month period and who have a VAS score of 3 or more
  • Individuals who can walk 10 meters independently (with or without ancillary device)

Exclusion Criteria:

  • Individuals with Body Mass Index 35 and above
  • Individuals with a history of surgery or injury involving the lower limb within the last 1 year (knee / hip endoprosthesis, post-fracture surgery, menisectomy, etc.)
  • Individuals who received hyaluronic acid or corticosteroid injections in the last year
  • People with severe eyesight, hearing disabilities Individuals with neurological deficit or disorder
  • Individuals with regular exercise habits in the last 6 months
  • Individuals with inflammatory rheumatic diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728387


Locations
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Cyprus
Eastern Mediterranen University
Famagusta, Cyprus, 99450
Sponsors and Collaborators
Eastern Mediterranean University
Investigators
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Study Director: Ender Angın, PhD Eastern Mediterranen University
Principal Investigator: Berkiye Kırmızıgil, PhD Eastern Mediterranean University
Principal Investigator: Gozde Iyigun, PhD Eastern Mediterranean University
Principal Investigator: Sevim Oksuz, PhD Eastern Mediterranean University
Principal Investigator: Unal Deger, MSc Eastern Mediterranean University
Principal Investigator: Filiz Can, Prof Hacettepe University
Principal Investigator: Levent Eker, MD Eastern Mediterranean University
Principal Investigator: Debra J. Rose, PhD California State University

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Responsible Party: Sevim Öksüz, Asst. Prof., Eastern Mediterranean University
ClinicalTrials.gov Identifier: NCT03728387     History of Changes
Other Study ID Numbers: ETK00-2018-0203
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sevim Öksüz, Eastern Mediterranean University:
osteoarthritis
exercise
balance
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases