TelerehabilitationNCT05839977
The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis
A study testing Individual telerehabilitation and Home exercises based on videos in people with Telerehabilitation, run by Charles University, Czech Republic at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Telerehabilitation
- What is being tested?
- Individual telerehabilitation and Home exercises based on videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Mar 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe cognitive deficits that would interfere with understanding exercise instructions
- presence of other disease adversely affecting balance impairment
Trial locations and contacts
2 sites in 1 country.
Klára Novotná, Ph.D. contact
Czechia2 sites, 2 recruiting
- Recruiting
Center for Demyelinating Disease (RS Center), First Faculty of Medicine, Charles University and General University Hospital in Prague
Prague, Karlovo Náměstí 32, 121 21
Dana Horáková, doc., +420 224 966 515, rscentrum@vfn.cz
Barbora Staníčková, Mgr., +420 722 955 353, barbora.stanickova@vfn.cz
- Recruiting
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
Dana Horáková, doc., +420 224 966 515, rscentrum@vfn.cz
Barbora Staníčková, Mgr., +420 722 955 353, barbora.stanickova@vfn.cz
About this study
Official title: Possibilities of Using Telerehabilitation for the Therapy of Balance and Walking Disorders in Patients With Multiple Sclerosis in Clinical Practice
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.
Read the 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.
- Conditions
- Telerehabilitation
- Being tested
- Individual telerehabilitation, Home exercises based on videos
- Keywords
- multiple sclerosis, telerehabilitation, remote rehabilitation, exergaming, balance
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual telerehabilitationOther
The exercise will consist of strength and balance exercises using the Homebalance ® system
Home exercises based on videosOther
intervention include 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise
| Study group | Role | What they receive |
|---|---|---|
| Individual telerehabilitation group | Experimental | 20 patients with multiple sclerosis Receives: Other: Individual telerehabilitation |
| Video based exercise group | Active comparator | 20 patients with multiple sclerosis Receives: Other: Home exercises based on videos |
| Control group | No intervention | 20 patients with multiple sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to week 12
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Mar 2023
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbora Staníčková, Charles University, Czech Republic
- Investigators
- Barbora Staníčková, Mgr., Principal investigator, First Faculty of Medicine, Charles University in Prague and General University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839977
- Sponsor's protocol ID
- CharlesUniversity
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possibilities of Using Telerehabilitation for the Therapy of Balance and Walking Disorders in Patients With Multiple Sclerosis in Clinical Practice
- ClinicalTrials.gov ID
- NCT05839977
- Acronym / sponsor ID
- CharlesUniversity
- Conditions
- Telerehabilitation
- Keywords
- multiple sclerosis, telerehabilitation, remote rehabilitation, exergaming, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual telerehabilitation group | Experimental | Other: Individual telerehabilitation20 patients with multiple sclerosis |
| Video based exercise group | Active comparator | Other: Home exercises based on videos20 patients with multiple sclerosis |
| Control group | No intervention | –20 patients with multiple sclerosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- severe cognitive deficits that would interfere with understanding exercise instructions
- presence of other disease adversely affecting balance impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual telerehabilitationThe exercise will consist of strength and balance exercises using the Homebalance ® system | Other | Individual telerehabilitation group |
| Home exercises based on videosintervention include 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise | Other | Video based exercise group |
Primary outcome
Change in balance (Berg Balance Scale)
Time frame: 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)
Time frame: 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 functional mobility (Timed Up and Go Cognitive)
Time frame: 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.
Change in balance (One leg stance)
Time frame: 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.
4 secondary outcomes
Change in balance (Activity Balance Scale)
Time frame: Baseline to week 12
Change in balance (Falls Efficacy Scale-I)
Time frame: Baseline to week 12
Change in walk (Multiple Sclerosis Walking Scale 12)
Time frame: Baseline to week 12
Change in fatigue (Modified Fatigue Impact Scale)
Time frame: Baseline to week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klára Novotná, Ph.D. contact
Barbora Staníčková, Mgr. principal investigator
First Faculty of Medicine, Charles University in Prague and General University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual telerehabilitation and Home exercises based on videos in people with Telerehabilitation, run by Charles University, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbora Staníčková, Mgr. (+420 722 955 353, barbora.stanickova@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in balance (Berg Balance Scale) (time frame: Baseline to week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.