The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis
Possibilities of Using Telerehabilitation for the Therapy of Balance and Walking Disorders in Patients With Multiple Sclerosis in Clinical Practice
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 20, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 3, 2023
April 1, 2023
2.6 years
April 20, 2023
April 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
Change in balance (Activity Balance Scale)
Baseline to week 12
Change in balance (Falls Efficacy Scale-I)
Baseline to week 12
Change in walk (Multiple Sclerosis Walking Scale 12)
Baseline to week 12
Change in fatigue (Modified Fatigue Impact Scale)
Baseline to week 12
Study Arms (3)
Individual telerehabilitation group
EXPERIMENTAL20 patients with multiple sclerosis
Video based exercise group
ACTIVE COMPARATOR20 patients with multiple sclerosis
Control group
NO INTERVENTION20 patients with multiple sclerosis
Interventions
The exercise will consist of strength and balance exercises using the Homebalance ® system
intervention include 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- severe cognitive deficits that would interfere with understanding exercise instructions
- presence of other disease adversely affecting balance impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for Demyelinating Disease (RS Center), First Faculty of Medicine, Charles University and General University Hospital in Prague
Prague, Karlovo Náměstí 32, 121 21, 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, 121 21, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbora Staníčková, Mgr.
First Faculty of Medicine, Charles University in Prague and General University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Possibilities of using telerehabilitation for the therapy of balance and walking disorders in patients with multiple sclerosis in clinical practice
Study Record Dates
First Submitted
April 20, 2023
First Posted
May 3, 2023
Study Start
March 1, 2023
Primary Completion
October 1, 2025
Study Completion
December 1, 2025
Last Updated
May 3, 2023
Record last verified: 2023-04