Tele-Assessment and Face-to-Face Evaluation of Functional Gait Assessment in Multiple Sclerosis
2021年6月13日 更新者：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.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
観察的
入学 (予想される)
32
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Perim Zengin, M.Sc
- 電話番号：+905318639943
- メール：perimzengin@gmail.com
研究場所
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Sisli
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Istanbul、Sisli、七面鳥、34384
- 募集
- Memorial Sisli Hospital, Neurology Clinic
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コンタクト：
- Perim Zengin, M.Sc
- 電話番号：+905318639943
- メール：perimzengin@gmail.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional Gait Assessment
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Timed 25-Foot Walk Test
時間枠：Baseline
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Perim Zengin, M.Sc、Istanbul University-Cerrahpasa Institute of Postgraduate Education
- スタディチェア：Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof.、Istanbul University-Cerrahpasa Faculty of Health Science
- スタディチェア：Burcu Altunrende, Prof. Dr.、Memorial Sisli Hospital, Neurology Clinic
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年1月26日
一次修了 (予想される)
2021年7月1日
研究の完了 (予想される)
2021年8月1日
試験登録日
最初に提出
2021年6月6日
QC基準を満たした最初の提出物
2021年6月13日
最初の投稿 (実際)
2021年6月21日
学習記録の更新
投稿された最後の更新 (実際)
2021年6月21日
QC基準を満たした最後の更新が送信されました
2021年6月13日
最終確認日
2021年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 12015
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
A video recording of the Functional Gait Assessment conducted in the clinic for inter-rater reliability analysis will be shared.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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