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

Multiple Sclerosis Clinical Trial

Official title:

The Agreement Between Face-to-Face and Tele-Assessment of Balance Tests in Patient With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743284
• Other study ID #: E-71938118-604.01.01-52315
• Status: Completed
• Start date: March 5, 2021
• Est. completion date: March 7, 2022

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Voluntary patients who have been diagnosed with MS will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. Tele-assessment will be applied to one group first, and face-to-face assessment will be applied to the other group first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 7, 2022
• Est. primary completion date: January 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa, Faculty of Health Science	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Korn T. Pathophysiology of multiple sclerosis. J Neurol. 2008 Dec;255 Suppl 6:2-6. doi: 10.1007/s00415-008-6001-2. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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