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

NCT03728387 | Completed

• 1 other identifier: ETK00-2018-0203
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee; Exercise; Balance

Keywords

osteoarthritis; exercise; balance

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (7)

• Socio-demographic evaluations

  it will be recorded at the beginning

• Berg Balance Test

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

• The Timed Up & Go (TUG) Test:

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

• Single Leg Stance Test

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

• Push and Release Test

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

Study Arms (1)

osteoarthritis and clinical pilates exercise

EXPERIMENTAL

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

Interventions

Clinical Pilates Exercise OTHER

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.

osteoarthritis and clinical pilates exercise

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranen University

Famagusta, 99450, Cyprus

Location

MeSH Terms

Conditions

Motor Activity; Osteoarthritis

Condition Hierarchy (Ancestors)

Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ender Angın, PhD

  Eastern Mediterranen University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 2, 2018
• Study Start: February 18, 2019
• Primary Completion: May 18, 2019
• Study Completion: June 20, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

CY (1)