Multiple SclerosisNCT06327789
Trunk Control and Disability in Persons With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2021to 21 Feb 2022
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: diagnosed with relapsing-remitting multiple sclerosis by an experienced neurologist
Who may be able to join
- 18-50 years old,
- diagnosed with RRMS by an experienced neurologist
- EDSS score ≤ 3
Who cannot join
- orthopedic or sensory additional problems in the lower extremity
- who had an interventional procedure in the last six months, and had an attack in the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Trunk Control and Disability in Persons With Early Relapsing Multiple Sclerosis
This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Twenty-three RRMS patients with an age range of 18-50 years, EDSS score ≤ 3 were included in this study. The patients' level of disability (EDSS), trunk control )Trunk Impairment Scale - TIS), lower extremity functionality (Timed 25-Foot Walk Test - T25FW), upper extremity functionality (Nine Hole Peg Test- 9HPT), balance (Biodex Balance System) and gait (Zebris® FDM 2) were evaluated.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Patients who were 18-50 years old, diagnosed with RRMS by a experienced neurologist, and with an EDSS score ≤ 3 were included in this study. Patients with orthopedic or sensory additional problems in the lower extremity, who had an interventional procedure in the last six months, and had an attack in the last three months were excluded from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale (EDSS)
EDSS was used to determine the patients' level of disability. EDSS is most commonly used to assess the level of disability in persons with MS. In this scale pyramidal, cerebral, cerebellar, brainstem, visual and sensory subparameters are evaluated it consists of ordinal rating system ranging from 0 (normal neurological status) to 10 (death due to MS) in 0.5 increments interval (when reaching EDSS 1). The lower scale values of the EDSS measure impairments based on the neurological examination, while the upper range of the scale (> EDSS 6) measures handicaps of patients with MS. The determination of EDSS 4 - 6 is heavily dependent on aspects of walking ability
Measured: up to 8 weeks
Trunk Impairment Scale (TIS)
This scale used to evaluate the trunk control of the participants, TIS contains static sitting balance, dynamic sitting balance, and coordination. The total score of this scale is from 0 to 23 and a high score indicates better trunk control. The patients were placed in the standard sitting position for the test and the parameters were applied. Standart position is such that the knees are flexed at 90 degrees, without back support, with the hands and forearms on the thighs and the feet in contact with the ground.
Measured: up to 8 weeks
Biodex Balance System (BBS) (MedicalSystems, Shirley, NY, USA)
This system is a multiaxial device that objectively measures and records a patient's ability to stabilize the involved joint under dynamic stress. The BBS measures, in degrees, the tilt about each axis during dynamic conditions and calculates a medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and an overall stability index (OSI). These indexes represent fluctuations around a zero point established before testing when the platform is stable. A high score in the all parameters indicates poor balance. The test was performed in 3 repetitions, each lasting 20 seconds, with a 10-second rest period in between, under different conditions, including eyes open-closed, firm-foam surface, and static-dynamic surface. The average of the three repetitions was calculated automatically by the device
Measured: up to 8 weeks
Step Length (cm)
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Measured: up to 8 weeks
Stride Length (cm)
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Measured: up to 8 weeks
Step Width (cm)
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Measured: up to 8 weeks
Cadence (steps/min)
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Measured: up to 8 weeks
Velocity (m/s)
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Measured: up to 8 weeks
Step time (s)
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Measured: up to 8 weeks
Stride time (s)
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Measured: up to 8 weeks
Timed 25-Foot Walk Test (T25FW)
This test is designed for the evaluation of lower extremity functions.Initiated at the participant's first step, the test concludes upon reaching the finish line. The participants are instructed to walk as expeditiously as feasible within a specified time frame without running. The duration taken to traverse the 25-foot distance, both for the outbound and return segments, is documented, and subsequently, the average of these two durations is calculated.
Measured: up to 8 weeks
Nine-Hole Peg Test (9HPT)
It is a short, standardized, quantitative test used to evaluate upper extremity function. In the test, patients are asked to pick up nine wooden pegs from a platform as quickly as possible and then place them back into the holes.In our study, the test was conducted twice for both the dominant and non-dominant hands, and the average completion time was recorded.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start21 Dec 2021
- Primary completion25 Dec 2021
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZUCAN TOKSAL, Zonguldak Bulent Ecevit University
- Investigators
- Bilge Piri Çınar, Principal investigator, Samsun UniversityGüngör Beyza Özvar Şenöz, Principal investigator, Yüksek İhtisas UniversityHasret Uçar, Principal investigator, Zonguldak Bulent Ecevit UniversitySerkan Özakbaş, Principal investigator, Dokuz Eylul UniversityMustafa Açıkgöz, Principal investigator, Zonguldak Bulent Ecevit UniversityNursena Ceylan, Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327789
- Sponsor's protocol ID
- ZBEU-MS
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Trunk Control and Disability in Persons With Early Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06327789
- Acronym / sponsor ID
- ZBEU-MS
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 25 Mar 2024 (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.
This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Twenty-three RRMS patients with an age range of 18-50 years, EDSS score ≤ 3 were included in this study. The patients' level of disability (EDSS), trunk control )Trunk Impairment Scale - TIS), lower extremity functionality (Timed 25-Foot Walk Test - T25FW), upper extremity functionality (Nine Hole Peg Test- 9HPT), balance (Biodex Balance System) and gait (Zebris® FDM 2) were evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | – | –Patients who were 18-50 years old, diagnosed with RRMS by a experienced neurologist, and with an EDSS score ≤ 3 were included in this study. Patients with orthopedic or sensory additional problems in the lower extremity, who had an interventional procedure in the last six months, and had an attack in the last three months were excluded from the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- diagnosed with relapsing-remitting multiple sclerosis by an experienced neurologist
Key inclusion criteria (3 listed)
- 18-50 years old,
- diagnosed with RRMS by an experienced neurologist
- EDSS score ≤ 3
Key exclusion criteria (2 listed)
- orthopedic or sensory additional problems in the lower extremity
- who had an interventional procedure in the last six months, and had an attack in the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expanded Disability Status Scale (EDSS)
Time frame: up to 8 weeks
EDSS was used to determine the patients' level of disability. EDSS is most commonly used to assess the level of disability in persons with MS. In this scale pyramidal, cerebral, cerebellar, brainstem, visual and sensory subparameters are evaluated it consists of ordinal rating system ranging from 0 (normal neurological status) to 10 (death due to MS) in 0.5 increments interval (when reaching EDSS 1). The lower scale values of the EDSS measure impairments based on the neurological examination, while the upper range of the scale (> EDSS 6) measures handicaps of patients with MS. The determination of EDSS 4 - 6 is heavily dependent on aspects of walking ability
Trunk Impairment Scale (TIS)
Time frame: up to 8 weeks
This scale used to evaluate the trunk control of the participants, TIS contains static sitting balance, dynamic sitting balance, and coordination. The total score of this scale is from 0 to 23 and a high score indicates better trunk control. The patients were placed in the standard sitting position for the test and the parameters were applied. Standart position is such that the knees are flexed at 90 degrees, without back support, with the hands and forearms on the thighs and the feet in contact with the ground.
Biodex Balance System (BBS) (MedicalSystems, Shirley, NY, USA)
Time frame: up to 8 weeks
This system is a multiaxial device that objectively measures and records a patient's ability to stabilize the involved joint under dynamic stress. The BBS measures, in degrees, the tilt about each axis during dynamic conditions and calculates a medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and an overall stability index (OSI). These indexes represent fluctuations around a zero point established before testing when the platform is stable. A high score in the all parameters indicates poor balance. The test was performed in 3 repetitions, each lasting 20 seconds, with a 10-second rest period in between, under different conditions, including eyes open-closed, firm-foam surface, and static-dynamic surface. The average of the three repetitions was calculated automatically by the device
Step Length (cm)
Time frame: up to 8 weeks
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Stride Length (cm)
Time frame: up to 8 weeks
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Step Width (cm)
Time frame: up to 8 weeks
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Cadence (steps/min)
Time frame: up to 8 weeks
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Velocity (m/s)
Time frame: up to 8 weeks
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Step time (s)
Time frame: up to 8 weeks
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Stride time (s)
Time frame: up to 8 weeks
The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.
Timed 25-Foot Walk Test (T25FW)
Time frame: up to 8 weeks
This test is designed for the evaluation of lower extremity functions.Initiated at the participant's first step, the test concludes upon reaching the finish line. The participants are instructed to walk as expeditiously as feasible within a specified time frame without running. The duration taken to traverse the 25-foot distance, both for the outbound and return segments, is documented, and subsequently, the average of these two durations is calculated.
Nine-Hole Peg Test (9HPT)
Time frame: up to 8 weeks
It is a short, standardized, quantitative test used to evaluate upper extremity function. In the test, patients are asked to pick up nine wooden pegs from a platform as quickly as possible and then place them back into the holes.In our study, the test was conducted twice for both the dominant and non-dominant hands, and the average completion time was recorded.
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 25 Mar 2024.
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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.
Bilge Piri Çınar principal investigator
Samsun University
Güngör Beyza Özvar Şenöz principal investigator
Yüksek İhtisas University
Hasret Uçar principal investigator
Zonguldak Bulent Ecevit 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 Zonguldak Bulent Ecevit 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 3 inclusion and 2 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 25 Mar 2024. 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?
Expanded Disability Status Scale (EDSS) (time frame: up to 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.