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

NCT04932616 | Unknown DMC

• 1 other identifier: 12015
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

teleassessment; functional gait assessment; balance; walk

Outcome Measures

Primary Outcomes (1)

• Functional Gait Assessment

  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

Secondary Outcomes (5)

• Timed 25-Foot Walk Test

  Baseline

• Timed Up and Go Test

  Baseline

• Berg Balance Test

  Baseline

• The Four Square Step Test

  Baseline

• 12-item Multiple Sclerosis Walking Scale

  Baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Having a definite diagnosis of MS of any clinical type according to the 2017 Mc Donalds criteria by a neurologist,
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Memorial Sisli Hospital, Neurology Clinic

Istanbul, Sisli, 34384, Turkey (Türkiye)

RECRUITING

Related Publications (13)

• 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.

  PMID: 31801829 BACKGROUND

• 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.

  PMID: 32607064 BACKGROUND

• 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.

  PMID: 31042118 BACKGROUND

• 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.

  PMID: 25854331 BACKGROUND

• 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.

  PMID: 29901487 BACKGROUND

• 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.

  PMID: 15449976 BACKGROUND

• 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.

  PMID: 22740603 BACKGROUND

• 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.

  PMID: 12525714 BACKGROUND

• 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.

  PMID: 18061618 BACKGROUND

• 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.

  PMID: 16754576 BACKGROUND

• 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.

  PMID: 32143957 BACKGROUND

• 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.

  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.

  PMID: 23641026 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Perim Zengin, M.Sc

  Istanbul University-Cerrahpasa Institute of Postgraduate Education

  PRINCIPAL INVESTIGATOR

• Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof.

  Istanbul University-Cerrahpasa Faculty of Health Science

  STUDY CHAIR

• Burcu Altunrende, Prof. Dr.

  Memorial Şişli Hospital, Neurology Clinic

  STUDY CHAIR

Central Study Contacts

Perim Zengin, M.Sc

CONTACT

+905318639943; perimzengin@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 21, 2021
• Study Start: January 26, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)