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Clinical Trials/NCT05839977
NCT05839977
Recruiting
N/A

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

Charles University, Czech Republic2 sites in 1 country60 target enrollmentMarch 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Telerehabilitation
Sponsor
Charles University, Czech Republic
Enrollment
60
Locations
2
Primary Endpoint
Change in balance (One leg stance)
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
December 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Charles University, Czech Republic
Responsible Party
Principal Investigator
Principal Investigator

Barbora Staníčková

Possibilities of using telerehabilitation for the therapy of balance and walking disorders in patients with multiple sclerosis in clinical practice

Charles University, Czech Republic

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

Outcomes

Primary Outcomes

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.

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 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 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.

Secondary Outcomes

  • Change in walk (Multiple Sclerosis Walking Scale 12)(Baseline to week 12)
  • Change in balance (Activity Balance Scale)(Baseline to week 12)
  • Change in balance (Falls Efficacy Scale-I)(Baseline to week 12)
  • Change in fatigue (Modified Fatigue Impact Scale)(Baseline to week 12)

Study Sites (2)

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