The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis

Telerehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839977
• Other study ID #: CharlesUniversity
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Charles University, Czech Republic
• Contact: Barbora Stanícková, Mgr.
• Phone: +420 722 955 353
• Email: barbora.stanickova[@]vfn.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Telerehabilitation

Intervention

Other:
• Individual telerehabilitation
The exercise will consist of strength and balance exercises using the Homebalance ® system
• Home exercises based on videos
intervention include 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise

Locations

Country	Name	City	State
Czechia	Center for Demyelinating Disease (RS Center), First Faculty of Medicine, Charles University and General University Hospital in Prague	Prague	Karlovo Námestí 32
Czechia	Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital in Prague	Prague	Karlovo Námestí 32

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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