Trial Review

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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] 296571 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 310362 0
Gait limitations 310363 0
Imbalance 310366 0
Sarcopenia 310818 0
Condition category
Condition code
Neurological 309093 309093 0 0
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] 313160 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308060 0
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] 308060 0
Single examination
Primary outcome [2] 308061 0
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] 308061 0
Single examination
Primary outcome [3] 308062 0
Changes in any and maximum gait speed measured with the 10 meter walk test and the Timed 25-Foot Walk Test.

Timepoint [3] 308062 0
Single examination
Secondary outcome [1] 353849 0
Fatigue assessed by the FSS fatigue scale.
Timepoint [1] 353849 0
Single examination
Secondary outcome [2] 353850 0
Efficiency in terms of activities of functional independence in the Barthel Index
Timepoint [2] 353850 0
Single examination
Secondary outcome [3] 354991 0
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] 354991 0
Single examination
Secondary outcome [4] 354992 0
Changes in gait performance measured using a 6-minute walk test. This is a primary outcome.
Timepoint [4] 354992 0
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?
No
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
90
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 21013 0
Poland
State/province [1] 21013 0
Podkarpackie

Funding & Sponsors
Funding source category [1] 301150 0
University
Name [1] 301150 0
University of Rzeszow
Country [1] 301150 0
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] 300770 0
None
Name [1] 300770 0
Address [1] 300770 0
Country [1] 300770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301898 0
The Ethical Committee of University of Rzeszow
Ethics committee address [1] 301898 0
University of Rzeszow, Aleja Rejtana 16c, 35-959 Rzeszow
Ethics committee country [1] 301898 0
Poland
Date submitted for ethics approval [1] 301898 0
25/09/2018
Approval date [1] 301898 0
11/10/2018
Ethics approval number [1] 301898 0
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 88478 0
Miss Gabriela Kolodziej
Address 88478 0
University of Rzeszow, Institute of Physiotherapy, ul. Hoffmanowej 25, 35-310 Rzeszow
Country 88478 0
Poland
Phone 88478 0
+48 17 872 2928
Fax 88478 0
Email 88478 0
[email protected]
Contact person for public queries
Name 88479 0
Miss Gabriela Kolodziej
Address 88479 0
University of Rzeszow, Institute of Physiotherapy, ul. Hoffmanowej 25, 35-310 Rzeszow
Country 88479 0
Poland
Phone 88479 0
+48 17 872 2928
Fax 88479 0
Email 88479 0
[email protected]
Contact person for scientific queries
Name 88480 0
Miss Gabriela Kolodziej
Address 88480 0
University of Rzeszow, Institute of Physiotherapy, ul. Hoffmanowej 25, 35-310 Rzeszow
Country 88480 0
Poland
Phone 88480 0
+48 17 872 2928
Fax 88480 0
Email 88480 0
[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.TypeCitationLinkEmailOther DetailsAttachment
191Ethical 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
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4105Plain language summaryNo -

Documents added automatically
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