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

NCT ID: NCT04932616

Last Updated: 2021-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-26

Study Completion Date

2021-08-01

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Tele- Assessment Group Functional Gait Assessment

The evaluation to be applied for the tele-evaluation reliability study of the scale:

Functional Gait Assessment

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Perim Zengin

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Perim Zengin, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University-Cerrahpasa Institute of Postgraduate Education

Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof.

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa Faculty of Health Science

Burcu Altunrende, Prof. Dr.

Role: STUDY_CHAIR

Memorial Şişli Hospital, Neurology Clinic

Locations

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Memorial Sisli Hospital, Neurology Clinic

Istanbul, Sisli, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Perim Zengin, M.Sc

Role: CONTACT

+905318639943

Facility Contacts

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Perim Zengin, M.Sc

Role: primary

+905318639943

References

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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.

Reference Type BACKGROUND
PMID: 16754576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31801829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32607064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31042118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25854331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29901487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15449976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22740603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12525714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18061618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32143957 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23641026 (View on PubMed)

Other Identifiers

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12015

Identifier Type: -

Identifier Source: org_study_id

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