The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis

April 21, 2023 updated by: Barbora Staníčková, Charles University, Czech Republic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Karlovo Náměstí 32
      • Prague, Karlovo Náměstí 32, Czechia, 121 21
        • Recruiting
        • Center for Demyelinating Disease (RS Center), First Faculty of Medicine, Charles University and General University Hospital in Prague
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dana Horáková, doc.
        • Sub-Investigator:
          • Klára Novotná, Ph.D.
      • Prague, Karlovo Náměstí 32, Czechia, 121 21
        • Recruiting
        • Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital in Prague
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dana Horáková, doc.
        • Sub-Investigator:
          • Klára Novotná, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual telerehabilitation group
20 patients with multiple sclerosis
Other: Individual telerehabilitation
The exercise will consist of strength and balance exercises using the Homebalance ® system
Active Comparator: Video based exercise group
20 patients with multiple sclerosis
Other: 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
No Intervention: Control group
20 patients with multiple sclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to week 12
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.
Baseline to week 12
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.
Baseline to week 12
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.
Baseline to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in balance (Activity Balance Scale)
Time Frame: 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.
Baseline to week 12
Change in balance (Falls Efficacy Scale-I)
Time Frame: 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).
Baseline to week 12
Change in walk (Multiple Sclerosis Walking Scale 12)
Time Frame: 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).
Baseline to week 12
Change in fatigue (Modified Fatigue Impact Scale)
Time Frame: 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.
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Principal Investigator: Barbora Staníčková, Mgr., First Faculty of Medicine, Charles University in Prague and General University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CharlesUniversity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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