The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis

Study Overview
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Brief Summary
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The study will compare the effect of individual telerehabilitation with offline remote exercise through videos and with a control group without intervention. The monitored group will be people with multiple sclerosis with balance impairment. The duration of the intervention will be 12 weeks.

Detailed Description
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Total of 60 persons will be randomly divided into two experimental and one control groups. After dividing into individual groups, all probands will be examined using objective and subjective tests for balance and walking. The same testing will be done after the end of the 12-week intervention. The group with individual telerehabilitation will exercise twice a week. The exercise will consist of strength and balance exercises using the Homebalance ® system. For direct synchronous contact between the physiotherapist and the patient, an audiovisual link via the freely available ZOOM app was used. The second experimental group will receive 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise twice a week. The control group receives no intervention.

Official Title
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Possibilities of Using Telerehabilitation for the Therapy of Balance and Walking Disorders in Patients With Multiple Sclerosis in Clinical Practice

Conditions
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Telerehabilitation

Intervention / Treatment
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* Other: Individual telerehabilitation
* Other: Home exercises based on videos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of definite MS subjectively perceived balance impairment clinically stable MS (at least 30 days since the last attack of the disease) ability to independently operate a PC or tablet, and Exclusion Criteria: severe cognitive deficits that would interfere with understanding exercise instructions presence of other disease adversely affecting balance impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual telerehabilitation group<br>20 patients with multiple sclerosis | Other: Individual telerehabilitation<br>* The exercise will consist of strength and balance exercises using the Homebalance ® system<br>|
| Active Comparator: Video based exercise group<br>20 patients with multiple sclerosis | Other: Home exercises based on videos<br>* intervention include 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise<br>|
| No Intervention: Control group<br>20 patients with multiple sclerosis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in balance (Berg Balance Scale) | Berg Balance Scale (BBS) is 14-item scale that evaluates balance.The 14 items are rated on either a 5-point (0-4) scale. | Baseline to week 12 | 
| Change in functional mobility (Timed Up and Go) | Timed Up and Go test (TUG) is test used to measure functional mobility. The TUG test measures how long it takes to stand up, walk a distance of 3 metres, turn, walk back, and sit down again. | Baseline to week 12 | 
| Change in functional mobility (Timed Up and Go Cognitive) | Timed Up and Go Cognitive (TUG Cognitive) is test used to measure functional mobility. The TUG test measures how long it takes to stand up, walk a distance of 3 metres, turn, walk back, and sit down again with an added cognitive task. | Baseline to week 12 | 
| Change in balance (One leg stance) | One leg stance is test that evaluates balance. In the test, the time for which the tested person can stand on one leg is measured. | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in balance (Activity Balance Scale) | Activity Balance Scale (ABC Scale) is a patient-reported outcome measure that asks individuals to rate how confident they are that they will not lose their balance while performing 16 different activities. | Baseline to week 12 | 
| Change in balance (Falls Efficacy Scale-I) | Falls Efficacy Scale-I (FES-I) is a questionnaire that assesses the fear of falling with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). | Baseline to week 12 | 
| Change in walk (Multiple Sclerosis Walking Scale 12) | Multiple Sclerosis Walking Scale 12 (MSWS-12) is self-report measure of the impact of multiple sclerosis on the individuals walking ability. The questionnaire consists of 12 questions and scoring for each item is from 0 (no limitation) to 5 (extreme limitation). | Baseline to week 12 | 
| Change in fatigue (Modified Fatigue Impact Scale) | Modified Fatigue Impact Scale (MFIS) is a questionnaire that assesses the impact of fatigue on physical, cognitive, and psychosocial functioning. MFIS consists of 21 items in scale 0-4 each item. | Baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, telerehabilitation, remote rehabilitation, exergaming, balance