Clinical trial NCT04932616: Tele-Assessment and Face-to-Face Evaluation of Functional Gait Assessment in Multiple Sclerosis
Official title: Use of the Functional Gait Assessment in Patients With Multiple Sclerosis: Examining Reliability Between Face-to-Face and Online Applications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: teleassessment
functional gait assessment
balance
walk
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis patients over the age of 18 who applied to the Memorial Sisli Hospital Neurology Outpatient Clinic and volunteered to participate in the study

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Functional Gait Assessment
timeFrame: change from baseline at 15 day
Secondary outcomes:
measure: Timed 25-Foot Walk Test
timeFrame: Baseline
measure: Timed Up and Go Test
timeFrame: Baseline
measure: Berg Balance Test
timeFrame: Baseline
measure: The Four Square Step Test
timeFrame: Baseline
measure: 12-item Multiple Sclerosis Walking Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Memorial Sisli Hospital, Neurology Clinic
state: Sisli
Study officials:
affiliation: Istanbul University-Cerrahpasa Institute of Postgraduate Education
name: Perim Zengin, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University-Cerrahpasa Faculty of Health Science
name: Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Memorial Şişli Hospital, Neurology Clinic
name: Burcu Altunrende, Prof. Dr.
role: STUDY_CHAIR
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