ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618002052213

Ethics application status

Approved

Date submitted

28/11/2018

Date registered

21/12/2018

Date last updated

20/01/2020

Date data sharing statement initially provided

21/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

The evaluation of muscle strength, balance, gait and fatigue in patients with multiple sclerosis

Scientific title

The evaluation of the relationship between muscle strength and gait, balance and fatigue in patients with multiple sclerosis

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multiple sclerosis

Gait limitations

Imbalance

Sarcopenia

Condition category

Condition code

Neurological

Multiple sclerosis

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The estimated time of examination for one patient is 2 hours. Patients with multiple sclerosis will participate in the study. The main aim of the study is to assess the relationship between muscular strength, balance, gait and the level of fatigue in people suffering from multiple sclerosis. The specific aims are: to assess the variability of isotonic contraction of extensor and flexors muscles of the knee joint depending on the severity of the disease symptoms; assessment of the relationship between the muscle strength of extensors and flexors of the knee joint and the balance and stability of the persons qualified for the tests; assessment of any and maximum gait speed depending on the severity of the disease process and depending on the strength of flexor and extensor muscles of the knee joints in people with multiple sclerosis; assessment of gait performance depending on the severity of the disease process and depending on the strength of the flexor and extensor muscles of the knee joints in people with multiple sclerosis; assessment of the relationship between fatigue and the strength of the extensor and flexor muscles of the knee joints. Research will take place at the Natural and Medical Research Center of Innovation of the University of Rzeszów. The following parameters will be used to assess the patient's condition: gait speed (measured using the 10 meter walk test and the Timed 25-Foot Walk Test); independent mobility (risk of falls) - measured using Time Up and Go Test; strength of the lower limb muscles - the measurement will be made using the Biodex System 4 Pro device; body balance (measured using the Neurocom Smart Equi Test); gait efficiency - a 6-min walk test will be performed; fatigue level - using the Fatigue Severity Scale (FSS) scale. At each test, the patient will be accompanied by a physiotherapist for the sake of protection.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The composite of the change in the strength of the flexor and extensor muscles of the knee joint evaluated using the Biodex System 4 Pro.

Timepoint [1]

Single examination

Primary outcome [2]

Change in the balance assessed using the Neurocom's Smart Equi Test. The time of latency will be evaluated for a slow, moderate and strong stimulus (motor control test).

Timepoint [2]

Single examination

Primary outcome [3]

Changes in any and maximum gait speed measured with the 10 meter walk test and the Timed 25-Foot Walk Test.

Timepoint [3]

Single examination

Secondary outcome [1]

Fatigue assessed by the FSS fatigue scale.

Timepoint [1]

Single examination

Secondary outcome [2]

Efficiency in terms of activities of functional independence in the Barthel Index

Timepoint [2]

Single examination

Secondary outcome [3]

Dynamic balance will be assessed by the Timed Up and Go Test and the choice stepping reaction time test. This is a primary outcome.

Timepoint [3]

Single examination

Secondary outcome [4]

Changes in gait performance measured using a 6-minute walk test. This is a primary outcome.

Timepoint [4]

Single examination.

Eligibility

Key inclusion criteria

Participants with Multiple Sclerosis (during remission), Expanded Disability Status Scale (EDSS) (2-6), able to walk independently (without assistance of other people, with orthopedic equipment if necessary).

Minimum age

25 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

the period of disease relapse, cognitive impairment that hinders understanding and acting in accordance with instructions (Mini Mental Scale below 24), unstable medical condition, contractures and orthopedic diseases of the lower limbs, coexisting other diseases disturbing gait or body balance.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/01/2019

Actual

2/01/2019

Date of last participant enrolment

Anticipated

3/02/2020

Actual

Date of last data collection

Anticipated

16/03/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Podkarpackie

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Rzeszow

Address [1]

University of Rzeszow, Aleja Rejtana 16c, 35-959 Rzeszow

Country [1]

Poland

Primary sponsor type

University

Name

University of Rzeszow

Address

University of Rzeszow, Aleja Rejtana 16c, 35-959 Rzeszow

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Ethical Committee of University of Rzeszow

Ethics committee address [1]

University of Rzeszow, Aleja Rejtana 16c, 35-959 Rzeszow

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

25/09/2018

Approval date [1]

11/10/2018

Ethics approval number [1]

8/10/2018

Summary

Brief summary

Multiple sclerosis belongs to the progressive diseases of the central nervous system. The lesions concern the structure of myelin sheaths in the brain and spinal cord. The main symptoms of the disease are limb paresis, sensory disturbances, visual disturbances, impaired motor coordination and balance, gait disturbances, fatigability and depression. Based on the review of domestic and foreign literature, it can be concluded that there are no studies on the relationship between muscular strength, degree of fatigue, gait and balance among people with multiple sclerosis depending on the disability level in the Extended Disability Status Scale (EDSS). The aim of the study will be to assess the relationship between muscular strength of the lower limbs and body balance, gait and fatigue in people with multiple sclerosis, taking into account the degree of disability described in the EDSS scale. Parameters assessed include: gait speed, independent mobility, body balance, strength of lower limbs and fatigue.
- gait speed - 10 meter walk test and Timed 25-Foot Walk Test
- independent mobility (risk of falls)
 - Time Up and Go Test- muscular strength in isokinetic conditions for extensors and flexors of the knee joint - Biodex System 4 Pro
- balance - computer dynamic posturography. The test will be performed at Neurocom's Smart Equi Test
- gait efficiency -  6 minute walk test

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Miss Gabriela Kolodziej

Address

University of Rzeszow, Institute of Physiotherapy, ul. Hoffmanowej 25, 35-310 Rzeszow

Country

Poland

Phone

+48 17 872 2928

Fax

[email protected]

Contact person for public queries

Name

Gabriela Kolodziej

Address

University of Rzeszow, Institute of Physiotherapy, ul. Hoffmanowej 25, 35-310 Rzeszow

Country

Poland

Phone

+48 17 872 2928

Fax

[email protected]

Contact person for scientific queries

Name

Gabriela Kolodziej

Address

University of Rzeszow, Institute of Physiotherapy, ul. Hoffmanowej 25, 35-310 Rzeszow

Country

Poland

Phone

+48 17 872 2928

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

The data on the results of clinical tests of balance and muscle strength parameters will be available.

When will data be available (start and end dates)?

The data will be made available within a period of one month after the last data collection.

From 1.06.2019 to 1.06.2021

Available to whom?

Researchers

Available for what types of analyses?

Cross sectional analysis

How or where can data be obtained?

In the excel file on the library repository page of the University of Rzeszow.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
191	Ethical approval					376355-(Uploaded-28-11-2018-20-05-06)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4105	Plain language summary	No		-

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically