Tele-Assessment and Face-to-Face Evaluation of Balance in MS

NCT04743284 | Completed

• 1 other identifier: E-71938118-604.01.01-52315
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

MS is characterized by clinical symptoms caused by lesions of the brain, spinal cord, or optic nerves that can affect balance, gait, and risk of falls. 50-80% of patients with MS have different levels of balance-related pathological findings. In addition, the imbalance is one of the most complained about findings by MS patients. Balance and postural control disorders are the most common signs in patients with cerebellar tract damage. Many patients have reported problems with balance and gait causing serious disability. Therefore, disorders of balance and postural control in patients with MS are associated with difficulty in standing and performing functional activities. Effective quantitative methods are needed to assess postural imbalance to help clinicians assess the progression of this disorder. Current literature suggests that home tele-rehabilitation and tele-medicine practices may be an alternative method effective enough to be equivalent to face-to-face physiotherapy treatments for patients with Ms. The advantages of Tele-medicine over normal care include increased social support, participant engagement, quality of care, cost-effectiveness, access to services (due to lack of transportation), and reducing the burden on healthcare professionals to make services easier to deploy. In cases such as Pandemic conditions, where face-to-face service is disrupted in clinics, tele-rehabilitation can be applied as a suitable alternative treatment method accessible to patients. The effectiveness of Tele-rehabilitation raises the question of whether tele-evaluation is as effective and accurate as in the clinic. Studies examining the effectiveness of Tele-assesment are still insufficient. The study is planned to address this deficiency. The aim of this study is to compare the results of MS patients by applying valid and reliable methods used in balance assessment with face-to-face and online access methods, thereby investigating the effectiveness of balance assessment through online access. The hypothesis in this study is that the results of the balance assessment with online access in MS patients will be consistent with the results of the balance assessment conducted face-to-face. H0: Tele-assessments of balance do not give the same results as face-to-face balance assessments in MS patients. H1: Tele-assessments of balance do not give the same results as face-to-face balance assessments in MS patients.

Conditions

Multiple Sclerosis

Keywords

Tele-medicine; Neurorehabilitation; Stability; Gait; Questionnaire

Outcome Measures

Primary Outcomes (3)

• Berg Balance Test

  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.

  change from baseline at 3rd day

• Dynamic Gait Index

  The scale measures mobility function and dynamic balance. The eight tasks of this scale include walking, walking with head turns, turning, walking over objects, walking around objects, and climbing up stairs. The performance is rated on a 4-point scale.

  change from baseline at 3rd day

• Timed Up and Go Test

  The test is a measure of dynamic balance. It requires individuals to get up from a chair, walk 3 feet, turn and sit. The time from the moment the individual lifts the pelvis from the chair until he or she returns with the pelvis in the chair is recorded in seconds.

  change from baseline at 3rd day

Study Arms (2)

tele-assessment

The balance evaluations will be applied by the tele-assessment method.

face-to-face assessment

The balance evaluations will be applied by the face-to-face assessment method in a clinical setting

Eligibility Criteria

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

Study Population

Patients who have been diagnosed with MS

You may qualify if:

• years
• Patients diagnosed with MS according to McDonald diagnostic criteria with an EDSS score of 0-6
• Internet presence in the environment where they will perform the evaluation
• Having an internet-based technological tool or having access to this tool
• Having someone to accompany the patient during the evaluation
• Agree to participate in the study
• Ability to understand and speak Turkish

You may not qualify if:

• Having had a new attack in the last 3 months
• Use high-dose corticosteroid therapy in the last 2 weeks
• Presence of orthopedic problems/problems that can cause balance problems
• Having cognitive disorders that will prevent him from communicating
• Having a level of visual and auditory problems that will prevent communication

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Cerrahpasa, Faculty of Health Science

Istanbul, Turkey (Türkiye)

Location

Related Publications (14)

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  PMID: 19300953 BACKGROUND

• Browne P, Chandraratna D, Angood C, Tremlett H, Baker C, Taylor BV, Thompson AJ. Atlas of Multiple Sclerosis 2013: A growing global problem with widespread inequity. Neurology. 2014 Sep 9;83(11):1022-4. doi: 10.1212/WNL.0000000000000768. No abstract available.

  PMID: 25200713 BACKGROUND

• Mazumder R, Murchison C, Bourdette D, Cameron M. Falls in people with multiple sclerosis compared with falls in healthy controls. PLoS One. 2014 Sep 25;9(9):e107620. doi: 10.1371/journal.pone.0107620. eCollection 2014.

  PMID: 25254633 BACKGROUND

• Cameron MH, Nilsagard Y. Balance, gait, and falls in multiple sclerosis. Handb Clin Neurol. 2018;159:237-250. doi: 10.1016/B978-0-444-63916-5.00015-X.

  PMID: 30482317 BACKGROUND

• Ilg W, Synofzik M, Brotz D, Burkard S, Giese MA, Schols L. Intensive coordinative training improves motor performance in degenerative cerebellar disease. Neurology. 2009 Dec 1;73(22):1823-30. doi: 10.1212/WNL.0b013e3181c33adf. Epub 2009 Oct 28.

  PMID: 19864636 BACKGROUND

• Nelson SR, Di Fabio RP, Anderson JH. Vestibular and sensory interaction deficits assessed by dynamic platform posturography in patients with multiple sclerosis. Ann Otol Rhinol Laryngol. 1995 Jan;104(1):62-8. doi: 10.1177/000348949510400110.

  PMID: 7832544 BACKGROUND

• Amatya B, Galea MP, Kesselring J, Khan F. Effectiveness of telerehabilitation interventions in persons with multiple sclerosis: A systematic review. Mult Scler Relat Disord. 2015 Jul;4(4):358-69. doi: 10.1016/j.msard.2015.06.011. Epub 2015 Jun 19.

  PMID: 26195057 BACKGROUND

• Bove R, Garcha P, Bevan CJ, Crabtree-Hartman E, Green AJ, Gelfand JM. Clinic to in-home telemedicine reduces barriers to care for patients with MS or other neuroimmunologic conditions. Neurol Neuroimmunol Neuroinflamm. 2018 Oct 2;5(6):e505. doi: 10.1212/NXI.0000000000000505. eCollection 2018 Nov.

  PMID: 30775409 BACKGROUND

• Jennett PA, Affleck Hall L, Hailey D, Ohinmaa A, Anderson C, Thomas R, Young B, Lorenzetti D, Scott RE. The socio-economic impact of telehealth: a systematic review. J Telemed Telecare. 2003;9(6):311-20. doi: 10.1258/135763303771005207.

  PMID: 14680514 BACKGROUND

• Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.

  PMID: 29275977 BACKGROUND

• Lord SE, Wade DT, Halligan PW. A comparison of two physiotherapy treatment approaches to improve walking in multiple sclerosis: a pilot randomized controlled study. Clin Rehabil. 1998 Dec;12(6):477-86. doi: 10.1191/026921598675863454.

  PMID: 9869251 BACKGROUND

• Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

  PMID: 6685237 BACKGROUND

• Cattaneo D, Jonsdottir J, Repetti S. Reliability of four scales on balance disorders in persons with multiple sclerosis. Disabil Rehabil. 2007 Dec 30;29(24):1920-5. doi: 10.1080/09638280701191859. Epub 2007 Apr 26.

  PMID: 17852286 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

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

• Ayşe Zengin Alpözgen, Asst.Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: March 5, 2021
• Primary Completion: January 16, 2022
• Study Completion: March 7, 2022
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

TU (1)