NCT05839977

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

2.6 years

First QC Date

April 20, 2023

Last Update Submit

April 21, 2023

Conditions

Keywords

multiple sclerosistelerehabilitationremote rehabilitationexergamingbalance

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

EXPERIMENTAL

20 patients with multiple sclerosis

Other: Individual telerehabilitation

Video based exercise group

ACTIVE COMPARATOR

20 patients with multiple sclerosis

Other: Home exercises based on videos

Control group

NO INTERVENTION

20 patients with multiple sclerosis

Interventions

The exercise will consist of strength and balance exercises using the Homebalance ® system

Individual telerehabilitation group

intervention include 12 video recordings of exercises created by a physiotherapist for home exercises, according to which they will also exercise

Video based exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

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, Czechia

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Barbora Staníčková, Mgr.

    First Faculty of Medicine, Charles University in Prague and General University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbora Staníčková, Mgr.

CONTACT

Klára Novotná, Ph.D.

CONTACT

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

Locations