Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03584672
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Fatih Söke, Gazi University

Brief Summary:
The aim of the study is to investigate reliability, validity, and responsiveness of the Static Balance Test in patients with Multiple Sclerosis.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Static Balance Test Other: Berg Balance Scale Other: Timed Up an Go Test Other: Four Square Step Test Other: Functional Reach Test Other: One-leg Stance Test

Detailed Description:
At baseline, the Static Balance Test, Berg Balance Scale, Timed Up and Go test, Functional Reach Test, Four Square Step Test, and One-legged Stance Test is applied to the Multiple Sclerosis group. The Static Balance Test is repeated after seven days from the first application in patients with Multiple Sclerosis. Healthy controls are going to perform only the Static Balance Test.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.
Estimated Study Start Date : August 5, 2018
Estimated Primary Completion Date : August 20, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with Multiple Sclerosis
Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score < 7)
Other: Static Balance Test
Balance control is assessed by the Static Balance Test.

Other: Berg Balance Scale
Functional balance is assessed by the Berg Balance Scale.

Other: Timed Up an Go Test
Functional mobility is assessed by the Timed Up and Go test.

Other: Four Square Step Test
Dynamic balance is assessed by the Four Square Step Test.

Other: Functional Reach Test
Limits of stability is assessed by the Functional Reach Test.

Other: One-leg Stance Test
Postural steadiness is assessed by the One-leg Stance Test.

Healthy Controls
Healthy people
Other: Static Balance Test
Balance control is assessed by the Static Balance Test.




Primary Outcome Measures :
  1. Static Balance Test [ Time Frame: 5 minutes ]

    The Static Balance Test is used to assess balance control. The Static Balance Test, consists of five posture-holding tasks (sitting, stride standing, close standing, one-foot standing on the unparalyzed leg, and one-foot standing on the paralyzed leg). Four grades, 1-4, are used to judge the ability of patients to hold these postures. The grade at which a subject is rated on a task is taken as the score for that task.

    Hence, the minimum Static Balance Test score is 5, and the maximum is 20. A higher score indicates better balance.



Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: 15 minutes ]
    Functional balance is assessed by using the Berg Balance Scale. During the test, participants are asked to perform 14 tasks frequently used in daily life activities. Each item is scored between 0 (unable to perform the task) and 4 (task is performed independently) according to the ability of the person while performing the task. The highest possible score is 56 points. A higher score indicates better balance.

  2. Timed Up and Go Test [ Time Frame: 1 minutes ]
    Functional mobility is assessed by using the timed up and go test. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair. A lower score indicates better functional mobility.

  3. Four Square Step Test [ Time Frame: 1 minutes ]
    The Four Square Step Test measures dynamic balance and clinically assesses the person's ability to step over objects forward, sideways, and backward. A square was formed by 4 canes resting flat on the floor. The participants were instructed to try and complete the sequence as fast as possible without touching the canes with both feet, making contact with the floor in each square. A lower score indicates better dynamic balance.

  4. One-leg Stance Test [ Time Frame: 5 minutes ]
    The clinical test of One-leg Stance Test assesses postural steadiness in a static position by a quantitative measurement i.e. the number of seconds a person can maintain the One-leg Stance Test position, thus implying that better postural steadiness would allow for longer standing on one leg.

  5. Functional Reach Test [ Time Frame: 30 seconds ]
    The Functional Reach Test assesses balance by measuring the limits while the patient reaches forwards as far as possible, having the arms in 90° flexion and without lifting the heels off the floor. A higher score indicates better limits of stability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Criteria

Inclusion Criteria:

  • at least 18 years,
  • neurologist-diagnosed Multiple Sclerosis,
  • Expanded Disability Status Scale (EDSS) score < 7,
  • able to walk 10 m with or without aids,
  • no MS exacerbation within the last 2 months,
  • use of stable medication in the last 2 months,

Exclusion Criteria:

  • other neurologic disorder,
  • Pregnancy,
  • orhopedic problems iaffecting gait and stance,
  • visual, auditory, orientational problems that could affect study results,
  • Cardiovascular, pulmonary, and humoral disease.

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): NCT03584672


Contacts
Layout table for location contacts
Contact: Faith Söke +90 506 932 81 02 fthsk_8993@hotmail.com
Contact: Arzu Güclü Gündüz arzuguclu@hotmail.com

Sponsors and Collaborators
Gazi University
Investigators
Layout table for investigator information
Principal Investigator: Fatih Söke Gazi University

Publications:
Layout table for additonal information
Responsible Party: Fatih Söke, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03584672     History of Changes
Other Study ID Numbers: 322
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fatih Söke, Gazi University:
Multiple Sclerosis
Static Balance Test
Balance
Reliability
Validity

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases