Clinical trial NCT05839977: The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis
Official title: Possibilities of Using Telerehabilitation for the Therapy of Balance and Walking Disorders in Patients With Multiple Sclerosis in Clinical Practice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Telerehabilitation
Keywords: multiple sclerosis
telerehabilitation
remote rehabilitation
exergaming
balance
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in balance (Berg Balance Scale)
timeFrame: Baseline to week 12
measure: Change in functional mobility (Timed Up and Go)
timeFrame: Baseline to week 12
measure: Change in functional mobility (Timed Up and Go Cognitive)
timeFrame: Baseline to week 12
measure: Change in balance (One leg stance)
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Change in balance (Activity Balance Scale)
timeFrame: Baseline to week 12
measure: Change in balance (Falls Efficacy Scale-I)
timeFrame: Baseline to week 12
measure: Change in walk (Multiple Sclerosis Walking Scale 12)
timeFrame: Baseline to week 12
measure: Change in fatigue (Modified Fatigue Impact Scale)
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Center for Demyelinating Disease (RS Center), First Faculty of Medicine, Charles University and General University Hospital in Prague
state: Karlovo Náměstí 32
city: Prague
country: Czechia
facility: Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital in Prague
state: Karlovo Náměstí 32
Study officials:
affiliation: First Faculty of Medicine, Charles University in Prague and General University Hospital
name: Barbora Staníčková, Mgr.
role: PRINCIPAL_INVESTIGATOR
References: