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The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis

Primary Purpose

Telerehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Individual telerehabilitation
Home exercises based on videos
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telerehabilitation focused on measuring multiple sclerosis, telerehabilitation, remote rehabilitation, exergaming, balance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Demyelinating Disease (RS Center), First Faculty of Medicine, Charles University and General University Hospital in PragueRecruiting
  • Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital in PragueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Individual telerehabilitation group

Video based exercise group

Control group

Arm Description

20 patients with multiple sclerosis

20 patients with multiple sclerosis

20 patients with multiple sclerosis

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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).
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).
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.

Full Information

First Posted
April 20, 2023
Last Updated
April 21, 2023
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT05839977
Brief Title
The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis
Official Title
Possibilities of Using Telerehabilitation for the Therapy of Balance and Walking Disorders in Patients With Multiple Sclerosis in Clinical Practice
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation
Keywords
multiple sclerosis, telerehabilitation, remote rehabilitation, exergaming, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual telerehabilitation group
Arm Type
Experimental
Arm Description
20 patients with multiple sclerosis
Arm Title
Video based exercise group
Arm Type
Active Comparator
Arm Description
20 patients with multiple sclerosis
Arm Title
Control group
Arm Type
No Intervention
Arm Description
20 patients with multiple sclerosis
Intervention Type
Other
Intervention Name(s)
Individual telerehabilitation
Intervention Description
The exercise will consist of strength and balance exercises using the Homebalance ® system
Intervention Type
Other
Intervention Name(s)
Home exercises based on videos
Intervention Description
intervention include 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise
Primary Outcome Measure Information:
Title
Change in balance (Berg Balance Scale)
Description
Berg Balance Scale (BBS) is 14-item scale that evaluates balance.The 14 items are rated on either a 5-point (0-4) scale.
Time Frame
Baseline to week 12
Title
Change in functional mobility (Timed Up and Go)
Description
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.
Time Frame
Baseline to week 12
Title
Change in functional mobility (Timed Up and Go Cognitive)
Description
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.
Time Frame
Baseline to week 12
Title
Change in balance (One leg stance)
Description
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.
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
Change in balance (Activity Balance Scale)
Description
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.
Time Frame
Baseline to week 12
Title
Change in balance (Falls Efficacy Scale-I)
Description
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).
Time Frame
Baseline to week 12
Title
Change in walk (Multiple Sclerosis Walking Scale 12)
Description
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).
Time Frame
Baseline to week 12
Title
Change in fatigue (Modified Fatigue Impact Scale)
Description
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.
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbora Staníčková, Mgr.
Phone
+420 722 955 353
Email
barbora.stanickova@vfn.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Klára Novotná, Ph.D.
Email
klara.novotna@vfn.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbora Staníčková, Mgr.
Organizational Affiliation
First Faculty of Medicine, Charles University in Prague and General University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Demyelinating Disease (RS Center), First Faculty of Medicine, Charles University and General University Hospital in Prague
City
Prague
State/Province
Karlovo Náměstí 32
ZIP/Postal Code
121 21
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Horáková, doc.
Phone
+420 224 966 515
Email
rscentrum@vfn.cz
First Name & Middle Initial & Last Name & Degree
Barbora Staníčková, Mgr.
Phone
+420 722 955 353
Email
barbora.stanickova@vfn.cz
First Name & Middle Initial & Last Name & Degree
Dana Horáková, doc.
First Name & Middle Initial & Last Name & Degree
Klára Novotná, Ph.D.
Facility Name
Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital in Prague
City
Prague
State/Province
Karlovo Náměstí 32
ZIP/Postal Code
121 21
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Horáková, doc.
Phone
+420 224 966 515
Email
rscentrum@vfn.cz
First Name & Middle Initial & Last Name & Degree
Barbora Staníčková, Mgr.
Phone
+420 722 955 353
Email
barbora.stanickova@vfn.cz
First Name & Middle Initial & Last Name & Degree
Dana Horáková, doc.
First Name & Middle Initial & Last Name & Degree
Klára Novotná, Ph.D.

12. IPD Sharing Statement

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The Effect of Telerehabilitation on Balance in People With Multiple Sclerosis

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