Tele-Assessment and Face-to-Face Evaluation of Functional Gait Assessment in Multiple Sclerosis
13 juin 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
32
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Perim Zengin, M.Sc
- Numéro de téléphone: +905318639943
- E-mail: perimzengin@gmail.com
Lieux d'étude
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Sisli
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Istanbul, Sisli, Turquie, 34384
- Recrutement
- Memorial Sisli Hospital, Neurology Clinic
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Contact:
- Perim Zengin, M.Sc
- Numéro de téléphone: +905318639943
- E-mail: perimzengin@gmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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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 |
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Tele- Assessment Group Functional Gait Assessment
The evaluation to be applied for the tele-evaluation reliability study of the scale: Functional Gait Assessment |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Functional Gait Assessment
Délai: change from baseline at 15 day
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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.
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change from baseline at 15 day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Timed 25-Foot Walk Test
Délai: 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.
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Baseline
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Timed Up and Go Test
Délai: Baseline
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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.
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Baseline
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Berg Balance Test
Délai: Baseline
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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.
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Baseline
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The Four Square Step Test
Délai: Baseline
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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.
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Baseline
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12-item Multiple Sclerosis Walking Scale
Délai: Baseline
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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.
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Baseline
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Perim Zengin, M.Sc, Istanbul University-Cerrahpasa Institute of Postgraduate Education
- Chaise d'étude: Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof., Istanbul University-Cerrahpasa Faculty of Health Science
- Chaise d'étude: Burcu Altunrende, Prof. Dr., Memorial Sisli Hospital, Neurology Clinic
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.
- Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with multiple sclerosis. Disabil Rehabil. 2006 Jun 30;28(12):789-95. doi: 10.1080/09638280500404289.
- Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.
- Kieseier BC, Pozzilli C. Assessing walking disability in multiple sclerosis. Mult Scler. 2012 Jul;18(7):914-24. doi: 10.1177/1352458512444498. Epub 2012 Apr 24.
- Hatcher-Martin JM, Adams JL, Anderson ER, Bove R, Burrus TM, Chehrenama M, Dolan O'Brien M, Eliashiv DS, Erten-Lyons D, Giesser BS, Moo LR, Narayanaswami P, Rossi MA, Soni M, Tariq N, Tsao JW, Vargas BB, Vota SA, Wessels SR, Planalp H, Govindarajan R. Telemedicine in neurology: Telemedicine Work Group of the American Academy of Neurology update. Neurology. 2020 Jan 7;94(1):30-38. doi: 10.1212/WNL.0000000000008708. Epub 2019 Dec 4.
- Forsberg A, Andreasson M, Nilsagard Y. The Functional Gait Assessment in People with Multiple Sclerosis: Validity and Sensitivity to Change. Int J MS Care. 2017 Mar-Apr;19(2):66-72. doi: 10.7224/1537-2073.2015-061.
- Yeroushalmi S, Maloni H, Costello K, Wallin MT. Telemedicine and multiple sclerosis: A comprehensive literature review. J Telemed Telecare. 2020 Aug-Sep;26(7-8):400-413. doi: 10.1177/1357633X19840097. Epub 2019 May 1.
- Khan F, Amatya B, Kesselring J, Galea M. Telerehabilitation for persons with multiple sclerosis. Cochrane Database Syst Rev. 2015 Apr 9;2015(4):CD010508. doi: 10.1002/14651858.CD010508.pub2.
- Moore JL, Potter K, Blankshain K, Kaplan SL, O'Dwyer LC, Sullivan JE. A Core Set of Outcome Measures for Adults With Neurologic Conditions Undergoing Rehabilitation: A CLINICAL PRACTICE GUIDELINE. J Neurol Phys Ther. 2018 Jul;42(3):174-220. doi: 10.1097/NPT.0000000000000229.
- Motl RW, Snook EM. Confirmation and extension of the validity of the Multiple Sclerosis Walking Scale-12 (MSWS-12). J Neurol Sci. 2008 May 15;268(1-2):69-73. doi: 10.1016/j.jns.2007.11.003. Epub 2007 Dec 3.
- Kirkwood RN, Batista NCL, Marques LBF, de Melo Ocarino J, Neves LLA, de Souza Moreira B. Cross-cultural adaptation and reliability of the Functional Gait Assessment in older Brazilian adults. Braz J Phys Ther. 2021 Jan-Feb;25(1):78-85. doi: 10.1016/j.bjpt.2020.02.004. Epub 2020 Feb 28.
- Weber, C., Schwieterman, M., Fier, K., Berni, J., Swartz, N., Phillips, R. S., & Reneker, J. C. (2016). Reliability and Validity of the Functional Gait Assessment: A Systematic Review. Physical & Occupational Therapy In Geriatrics, 34(1), 88-103.
- Forsberg A, Andreasson M, Nilsagard YE. Validity of the dynamic gait index in people with multiple sclerosis. Phys Ther. 2013 Oct;93(10):1369-76. doi: 10.2522/ptj.20120284. Epub 2013 May 2.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
26 janvier 2021
Achèvement primaire (Anticipé)
1 juillet 2021
Achèvement de l'étude (Anticipé)
1 août 2021
Dates d'inscription aux études
Première soumission
6 juin 2021
Première soumission répondant aux critères de contrôle qualité
13 juin 2021
Première publication (Réel)
21 juin 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 juin 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 juin 2021
Dernière vérification
1 juin 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12015
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
A video recording of the Functional Gait Assessment conducted in the clinic for inter-rater reliability analysis will be shared.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .