- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04932616
Tele-Assessment and Face-to-Face Evaluation of Functional Gait Assessment in Multiple Sclerosis
Use of the Functional Gait Assessment in Patients With Multiple Sclerosis: Examining Reliability Between Face-to-Face and Online Applications
Обзор исследования
Статус
Условия
Подробное описание
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Контакты исследования
- Имя: Perim Zengin, M.Sc
- Номер телефона: +905318639943
- Электронная почта: perimzengin@gmail.com
Места учебы
-
-
Sisli
-
Istanbul, Sisli, Турция, 34384
- Рекрутинг
- Memorial Sisli Hospital, Neurology Clinic
-
Контакт:
- Perim Zengin, M.Sc
- Номер телефона: +905318639943
- Электронная почта: perimzengin@gmail.com
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
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)
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
---|
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 |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Functional Gait Assessment
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Timed 25-Foot Walk Test
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Следователи
- Главный следователь: Perim Zengin, M.Sc, Istanbul University-Cerrahpasa Institute of Postgraduate Education
- Учебный стул: Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof., Istanbul University-Cerrahpasa Faculty of Health Science
- Учебный стул: Burcu Altunrende, Prof. Dr., Memorial Sisli Hospital, Neurology Clinic
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 12015
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .