Tele-Assessment and Face-to-Face Evaluation of Functional Gait Assessment in Multiple Sclerosis

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Recruiting

CT.gov ID

NCT04932616

Collaborator

(none)

Enrollment

Location

6.1

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to examine the reliability of the method by applying the Functional Gait Assessment in patients with Multiple Sclerosis via online video conferencing. For this purpose, walking of each patient to be included in the study; The evaluation results will be compared and the intra-rater reliability will be investigated by evaluating both face-to-face and online video conferencing methods. Since the Functional Gait Assessment is not available in Turkish, the scale will also be validated by adapting it to Turkish within the scope of the study.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis

Detailed Description

As with all neurological diseases, it is important to use appropriate outcome measurements in the assessment of balance and gait disorders in patients with Multiple Sclerosis (MS), in order to determine the appropriate program for the patient in physiotherapy and rehabilitation applications, both face-to-face and through telerehabilitation. The scale recommended by a clinical practice guide developed with the support of the American Physiotherapy Association (APTA) and the Academy of Neurological Physiotherapy (ANPT) is the Functional Gait Assessment (FGA). According to this proposal, a Turkish version will be made within the scope of the study so that functional walking evaluation can be used in our country. A 2017 study on functional gait assessment and Multiple Sclerosis investigated the validity and sensitivity to changes in the original English version of the test in multiple sclerosis, and as a result, its validity was found for MS. Functional gait assessment does not have a reliability study for Multiple Sclerosis.

Study Design

Study Type:

Observational

Anticipated Enrollment :

32 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Use of the Functional Gait Assessment in Patients With Multiple Sclerosis: Examining Reliability Between Face-to-Face and Online Applications

Actual Study Start Date :

Jan 26, 2021

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Face To Face (Clinic) Group Functional Gait Assessment Evaluations to be applied for the cultural adaptation and reliability study of the scale: Functional Gait Assessment, Timed Up and Go Test, Four-Step Square Test, Timed 25-Foot Walk Test, 12-Item Multiple Sclerosis Walking Scale Berg Balance Scale
Tele- Assessment Group Functional Gait Assessment The evaluation to be applied for the tele-evaluation reliability study of the scale: Functional Gait Assessment

Outcome Measures

Primary Outcome Measures

Functional Gait Assessment [change from baseline at 15 day]
The Functional Gait Assessment is a test designed to assess balance during various walking tasks. This test is a modification of the Dynamic Gait Index to increase reliability and reduce the ceiling effect. This test, which consists of 10 items, evaluates dynamic balance skills such as walking at normal and different speeds, walking with horizontal and vertical head movements, turning quickly, walking over objects, toe-heel walking, walking backwards, walking with eyes closed, and climbing stairs. Each item is scored between 0-3 points; 0 indicates that he is unable to perform that skill or severe gait or balance disorder is observed while performing that skill, and 3 indicates that he has achieved that skill normally. Points 1 and 2 are scored for each task separately for specific situations. Items are added to score the FGA and the maximum total score is set as 30.

Secondary Outcome Measures

Timed 25-Foot Walk Test [Baseline]
It is a performance test that provides information about the participant's mobility and leg function. The standardized protocol is very simple. The participant will be requested to walk as quickly and safely as possible (ie maximum walking speed) along a clearly marked, linear 25 feet or 7.62 m track. The participant can use an assistive device while walking. The person will walk two different times on the marked track and the average of two consecutive attempts in seconds will be recorded as a result of the test.
Timed Up and Go Test [Baseline]
It is a test used to evaluate dynamic balance. The test measures the time it takes a participant to get up from the chair and walk 3 meters at a comfortable pace and return to the chair and sit down. The test begins when the participant gets up from the chair and ends when the participant sits down on the chair again. The time measured is recorded in seconds. A shorter period represents better mobility.
Berg Balance Test [Baseline]
It is a scale containing 14 instructions and a score of 0-4 is given by observing the patient's performance for each instruction. 0 points are given in cases where the patient cannot perform the activity at all, while 4 points are given when the patient completes the activity independently. The highest score is 56 and 0-20 points indicate balance disorder, 21-40 points indicate an acceptable balance, 41-56 points indicate the presence of a good balance. It takes between 10 and 20 minutes to complete the scale.
The Four Square Step Test [Baseline]
The Four Square Step Test (FSST) is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward.
12-item Multiple Sclerosis Walking Scale [Baseline]
The Multiple Sclerosis Walking Scale (MSWS-12) is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Having a definite diagnosis of MS of any clinical type according to the 2017 Mc Donalds criteria by a neurologist,
18 years and over
Expanded Disability Status Scale (EDSS) score of 2,5-6
Not having an attack within the last 30 days
Voluntarily giving consent to participate in the study
Absence of visual and auditory impairment for completion of assessments

For Tele-assessment:

Having a walking area of at least 3 meters at home to evaluate walking
Providing a care provider's supervision to ensure walking safety
The patient or the caregiver can use the video conferencing software application from the phone or computer

Exclusion Criteria:

Diagnosis of another neurological disease that affects the level of ambulation other than MS
Receiving corticosteroid therapy within the last 1 month
Limitation in range of motion of the lower extremities, which may affect standing and walking
Pain that negatively affects walking in the lower extremity and lumbar area (etc., coxarthrosis, gonarthrosis, sciatica)
Inability to stand up from a sitting position (Timed Up & Go Test requirement)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sisli Hospital, Neurology Clinic	Istanbul	Sisli	Turkey	34384

Sponsors and Collaborators

Istanbul University-Cerrahpasa

Investigators

Principal Investigator: Perim Zengin, M.Sc, Istanbul University-Cerrahpasa Institute of Postgraduate Education
Study Chair: Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof., Istanbul University-Cerrahpasa Faculty of Health Science
Study Chair: Burcu Altunrende, Prof. Dr., Memorial Şişli Hospital, Neurology Clinic