The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis
- Conditions
- Telerehabilitation
- Interventions
- Other: Individual telerehabilitationOther: Home exercises based on videos
- Registration Number
- NCT05839977
- Lead Sponsor
- Charles University, Czech Republic
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- severe cognitive deficits that would interfere with understanding exercise instructions
- presence of other disease adversely affecting balance impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individual telerehabilitation group Individual telerehabilitation 20 patients with multiple sclerosis Video based exercise group Home exercises based on videos 20 patients with multiple sclerosis
- Primary Outcome Measures
Name Time Method Change in balance (One leg stance) Baseline to week 12 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.
Change in functional mobility (Timed Up and Go) Baseline to week 12 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.
Change in balance (Berg Balance Scale) Baseline to week 12 Berg Balance Scale (BBS) is 14-item scale that evaluates balance.The 14 items are rated on either a 5-point (0-4) scale.
Change in functional mobility (Timed Up and Go Cognitive) Baseline to week 12 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.
- Secondary Outcome Measures
Name Time Method Change in walk (Multiple Sclerosis Walking Scale 12) Baseline to week 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).
Change in balance (Activity Balance Scale) Baseline to week 12 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.
Change in balance (Falls Efficacy Scale-I) Baseline to week 12 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).
Change in fatigue (Modified Fatigue Impact Scale) Baseline to week 12 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.
Trial Locations
- Locations (2)
Center for Demyelinating Disease (RS Center), First Faculty of Medicine, Charles University and General University Hospital in Prague
🇨🇿Prague, Karlovo Náměstí 32, Czechia
Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital in Prague
🇨🇿Prague, Karlovo Náměstí 32, Czechia