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

13 juni 2021 uppdaterad av: Perim Zengin, Istanbul University - Cerrahpasa (IUC)

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

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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

32

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kalkon
    • Sisli
      • Istanbul, Sisli, Kalkon, 34384
        • Rekrytering
        • Memorial Sisli Hospital, Neurology Clinic
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional Gait Assessment
Tidsram: 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.
change from baseline at 15 day

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Timed 25-Foot Walk Test
Tidsram: 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.
Baseline
Timed Up and Go Test
Tidsram: 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.
Baseline
Berg Balance Test
Tidsram: 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.
Baseline
The Four Square Step Test
Tidsram: 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.
Baseline
12-item Multiple Sclerosis Walking Scale
Tidsram: 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.
Baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Utredare

  • Huvudutredare: Perim Zengin, M.Sc, Istanbul University-Cerrahpasa Institute of Postgraduate Education
  • Studiestol: Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof., Istanbul University-Cerrahpasa Faculty of Health Science
  • Studiestol: Burcu Altunrende, Prof. Dr., Memorial Sisli Hospital, Neurology Clinic

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 januari 2021

Primärt slutförande (Förväntat)

1 juli 2021

Avslutad studie (Förväntat)

1 augusti 2021

Studieregistreringsdatum

Först inskickad

6 juni 2021

Först inskickad som uppfyllde QC-kriterierna

13 juni 2021

Första postat (Faktisk)

21 juni 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 juni 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juni 2021

Senast verifierad

1 juni 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 12015

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

A video recording of the Functional Gait Assessment conducted in the clinic for inter-rater reliability analysis will be shared.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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