Clinical trial NCT04743284: Tele-Assessment and Face-to-Face Evaluation of Balance in MS
Official title: The Agreement Between Face-to-Face and Tele-Assessment of Balance Tests in Patient With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Tele-medicine
Neurorehabilitation
Stability
Gait
Questionnaire
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with MS

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Berg Balance Test
timeFrame: change from baseline at 3rd day
measure: Dynamic Gait Index
timeFrame: change from baseline at 3rd day
measure: Timed Up and Go Test
timeFrame: change from baseline at 3rd day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa, Faculty of Health Science
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayşe Zengin Alpözgen, Asst.Prof.
role: PRINCIPAL_INVESTIGATOR
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