Multiple SclerosisNCT04548310
Muscle Fatigue in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
It is stated that 85% of patients with Multiple Sclerosis (MS) complain of gait disorders and 35-90% of them have fatigue. Many factors play a role in the fatigue mechanism in MS patients. Fatigue can increase the symptoms that already exist in MS patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Muscles Fatigue
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Sep 2020to 27 May 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ambulatory sample
Who may be able to join
- Participants who 18-65 years of age
- MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month
Who cannot join
- Participants who have orthopedic, vision, hearing, or perception problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Muscle Fatigue on Strength, Joint Position Sensation, and Walking in Patients With Multiple Sclerosis
It is stated that 85% of patients with Multiple Sclerosis (MS) complain of gait disorders and 35-90% of them have fatigue. Many factors play a role in the fatigue mechanism in MS patients. Fatigue can increase the symptoms that already exist in MS patients. It is thought that fatigue caused a decrease in muscle strength, making walking worse. There are not enough studies investigating whether fatigue affects gait parameters in MS patients.
The aim of this study is to examine the effects of muscle fatigue on muscle strength, joint position sensation, and gait in MS patients.
Read the detailed description
Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The muscle strength, joint position sensation, gait, and fatigue will be evaluated once.
The investigators will use descriptive statistics and t-tests to compare demographic characteristics between groups and for the categorical variables chi-square. Effect of the group (MS patients or healthy controls), condition (Single task and dual-task conditions), and group × condition interaction will be compared using two-way repeated-measures ANOVA.
- Conditions
- Multiple Sclerosis
- Being tested
- Muscles Fatigue
- Keywords
- Multiple Sclerosis, gait, sensation, fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscles FatigueOther
An exhaustion protocol that reduces knee joint flexor and extensor torque will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis | MS patients (EDSS: 0-5,5) Receives: Other: Muscles Fatigue | |
| Healthy group | Healthy individuals without chronic disease Receives: Other: Muscles Fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee proprioception
Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).
Measured: 10 minutes
Knee strength
Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).
Measured: 20 minutes
Gait
Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.
Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica.
Measured: 5 minutes
Perceived Exertion
The Borg Rating of Perceived Exertion (RPE) scale is a tool for measuring an individual's effort and exertion, breathlessness, and fatigue.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start14 Sep 2020
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Ozkul, Gazi University
- Investigators
- Cagla Ozkul, Phd, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548310
- Sponsor's protocol ID
- 867
- Status last verified
- Aug 2022
- First submitted
- 7 Sep 2020
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suzuki, F. S., Mazuchi, F. A. S., Miranda, M. L. J., Maifrino, L. B. M., Mochizuki, L., & Ervilha, U. F. (2013). What is the most effective protocol to induce fatigue in knee joint muscles? a systematic review. J. Morphol, 30(3), 143-147.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Fatigue on Strength, Joint Position Sensation, and Walking in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04548310
- Acronym / sponsor ID
- 867
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, gait, sensation, fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is stated that 85% of patients with Multiple Sclerosis (MS) complain of gait disorders and 35-90% of them have fatigue. Many factors play a role in the fatigue mechanism in MS patients. Fatigue can increase the symptoms that already exist in MS patients. It is thought that fatigue caused a decrease in muscle strength, making walking worse. There are not enough studies investigating whether fatigue affects gait parameters in MS patients.
The aim of this study is to examine the effects of muscle fatigue on muscle strength, joint position sensation, and gait in MS patients.
Detailed description
Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The muscle strength, joint position sensation, gait, and fatigue will be evaluated once.
The investigators will use descriptive statistics and t-tests to compare demographic characteristics between groups and for the categorical variables chi-square. Effect of the group (MS patients or healthy controls), condition (Single task and dual-task conditions), and group × condition interaction will be compared using two-way repeated-measures ANOVA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis | – | Other: Muscles FatigueMS patients (EDSS: 0-5,5) |
| Healthy group | – | Other: Muscles FatigueHealthy individuals without chronic disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ambulatory sample
Key inclusion criteria (2 listed)
- Participants who 18-65 years of age
- MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month
Key exclusion criteria (1 listed)
- Participants who have orthopedic, vision, hearing, or perception problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscles FatigueAn exhaustion protocol that reduces knee joint flexor and extensor torque will be applied. | Other | Healthy group, Patients with Multiple Sclerosis |
Primary outcome
Knee proprioception
Time frame: 10 minutes
Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).
Knee strength
Time frame: 20 minutes
Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).
Gait
Time frame: 5 minutes
Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed. Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica.
Perceived Exertion
Time frame: 1 minute
The Borg Rating of Perceived Exertion (RPE) scale is a tool for measuring an individual's effort and exertion, breathlessness, and fatigue.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- BackgroundSuzuki, F. S., Mazuchi, F. A. S., Miranda, M. L. J., Maifrino, L. B. M., Mochizuki, L., & Ervilha, U. F. (2013). What is the most effective protocol to induce fatigue in knee joint muscles? a systematic review. J. Morphol, 30(3), 143-147.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cagla Ozkul, Phd principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee proprioception (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04548310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.