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Osteo Arthritis KneeNCT03728387

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

A study testing Clinical Pilates Exercise in people with Osteo Arthritis Knee and Exercise, run by Eastern Mediterranean University at 1 site in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Osteo Arthritis Knee, Exercise, Balance
What is being tested?
Clinical Pilates Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteCyprus
Study dates
18 Feb 2019to 20 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Cyprus1 site
  • Eastern Mediterranen University

    Famagusta, 99450

Other trials in Cyprus

About this study

Official title: The Validity, Reliability and Responsiveness of the Fullerton Advanced Balance (FAB-T) Scale in Patients With Osteoarthritis

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.

Read the detailed description

Osteoarthritis (OA) is the most common joint disorder (1). OA is seen 7 times more than rheumatoid artritis. It is the most important cause of disability seen with advanced age (1). It's a degenerative joint disease, usually associated with progressing age and characterized by biochemical and morphological changes in the synovial membrane and joint capsule, erosion of the joint cartilage, hypertrophy of the joint edges, subchondral sclerosis (2).

OA, an important public health problem, affects the knee joint most frequently (3). While the most important risk factor is age, there are many other risk factors such as race, sex, obesity, genetics and trauma. In osteoarthritis; joint is damaged due to the imbalance between formation and destruction. It causes progressive joint damage, pain, physical disability, and psychological disorders (4). The clinical characteristics of OA include pain, stiffness, limitation of motion, crepitation, varying degrees of inflammation and effusion, disability, functional disability, loss of daily living activities, deterioration in quality of life. (4,5). Pain is diminished by increased resting and alleviated by movement but advanced stages may also include resting pain and night pain. (6) In painful, swollen joints; loss of function is inevitable. The loss of function is specific to the site which is being involved. In knee OA, difficulty in squatting and climbing stairs, walking distance reduction and fatigue, antalgic gait can be seen (7). These complaints are often associated with instability. With increasing age, the frequency of OA also increases. The presence of knee OA in addition to the complications associated with aging especially affects the quality of life negatively. In addition to the physiological effects of advancing age; pain, functional restriction, loss of proprioception and instability due to knee OA may lead to a decrease in balance and, consequently, to falls, which may lead to undesirable outcomes. The determination of the balance problems in OA patients is also important in planning the treatment protocol to be given and also in evaluating the effectiveness of the treatment. There are valid and reliable scales in Turkish language which assess balance.

However, validity and reliability specific to the disease are also important for doing the assessment safeley in that population.

The Fullerton Advanced Balance Scale (FAB) was developed by Debbie Rose in 2006 to evaluate patients with a high risk of falling. The test uses dynamic and static equilibrium in different situations to determine balance problems in the elderly. The test has 10 parameters. These are: feet adjacent and eyes closed standing, reaching out forward to reach a shoulder-length object, turning in right and left directions in 360 degrees, stepping and passing over a 15.24 cm-length stair, tandem march, standing on one leg, eyes closed standing 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).

According to the power analysis,a total number of 84 knee osteoarthritis patients, aged between 40 and 65 years of age will be included in the study. Individuals will be given written and oral information about the study and their written approvals will be obtained. * The Turkish version of the Fullerton Advanced Balance Scale (FAB) was obtained with permission from Debbie Rose who developed the scale and it is used on the elderly before. Study pattern: Familiarization will be made to the physiotherapists before the study. Information about the all scales will be given in detail with practical application. The study will be performed on 3 different days and by a single physiotherapist. 1st Evaluation: All evaluations of the individuals included in the study will be done by the physiotherapist (sociodemographic evaluations, implementation of FAB-T and other balance scales). In addition, to determine the acceptability of the FAB-T scale, the time during the FAB-T application will be recorded. 2nd 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. 3rd Evaluation: After 6 weeks of treatment, the FAB-T scale will be applied to all individuals included in the study. The first two evaluations will be made for all participants. After the second evaluation is completed, 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 strenght training and a cool-down section. Various exercise methods (clinical pilates exercises) and tools will be utilized to improve balance and mobility. Third assessment will be applied only to individuals participating in the 6-week exercise training program. With the study design, the reliability of testing and retesting ability of the FAB-T scale, its validity with respect to its correlation with other balance scales, its acceptability with the application period and its sensitivity to change after 6 weeks of treatment will be evaluated.

Being tested
Clinical Pilates Exercise
Keywords
osteoarthritis, exercise, balance
Medical subject headings
Motor Activity, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical Pilates ExerciseOther

    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.

Study groups in NCT03728387
Study groupRoleWhat they receive
osteoarthritis and clinical pilates exerciseExperimental34 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.
Receives: Other: Clinical Pilates Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fullerton Advanced Balance Scale (FAB-T):

    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).

    Measured: Change will be assessed from the baseline at 1 week and 6th week.

Secondary outcomes (7)
  1. Socio-demographic evaluations

    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.

    Measured: it will be recorded at the beginning

  2. Berg Balance Test

    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).

    Measured: First evaluation will be applied on the first day and after 6 weeks.

  3. The Timed Up & Go (TUG) Test:

    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).

    Measured: First evaluation will be applied on the first day and after 6 weeks.

  4. Single Leg Stance Test

    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.

    Measured: First evaluation will be applied on the first day and after 6 weeks.

  5. Push and Release Test

    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).

    Measured: First evaluation will be applied on the first day and after 6 weeks.

  6. 30 Seconds Sit and Stand Up Test

    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).

    Measured: First evaluation will be applied on the first day and after 6 weeks.

  7. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index:

    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.

    Measured: First evaluation will be applied on the first day and after 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start18 Feb 2019
  3. Primary completion18 May 2019
  4. Study completion20 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03728387
Sponsor's protocol ID
ETK00-2018-0203
Status last verified
Nov 2019
First submitted
26 Oct 2018
Last updated
19 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Pilates Exercise in people with Osteo Arthritis Knee and Exercise, run by Eastern Mediterranean University at 1 site in Cyprus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fullerton Advanced Balance Scale (FAB-T): (time frame: Change will be assessed from the baseline at 1 week and 6th week.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.

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