Multiple SclerosisNCT05821257
Arm Swing During Walking in Early Multiple Sclerosis
An observational study of Multiple Sclerosis and Upper Extremity Problem, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis (MS) is the most common central nervous system inflammatory demyelinating disease which causes motor and sensory deficits, cerebellar symptoms, and balance problems. Due to these symptoms, gait abnormalities are common in MS, even in patients with low degrees of impairment. 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, Upper Extremity Problem, Gait Disorders, Neurologic
- What is being tested?
- Evaluation of the arm swing during gait and Functional Tests
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 30 Jun 2023
- 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: Eighteen MS outpatients from a hospital and 10 healthy controls were included. The patients who were diagnosed with MS in the last 30 days, were recovered from their symptoms and were clinically stable were included. Patients who had an acute medical illness in the past 6 months, any other neurological and psychiatric diseases, and any orthopedic, rheumatologic, or vestibular conditions that affect walking were excluded. The patients who had exacerbations between the first and second evaluations (three months after the first evaluation) were excluded.
Who may be able to join
- Patients who were diagnosed with MS in the last 30 days,
- Patients who were recovered from their symptoms and were clinically stable
Who cannot join
- Patients who had an acute medical illness in the past 6 months, any other neurological and psychiatric diseases
- Patients who had any orthopedic, rheumatologic, or vestibular conditions that affect walking
- Patients who had exacerbations between the first and second evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Multiple sclerosis (MS) is the most common central nervous system inflammatory demyelinating disease which causes motor and sensory deficits, cerebellar symptoms, and balance problems. Due to these symptoms, gait abnormalities are common in MS, even in patients with low degrees of impairment. The upper limb has an important role on postural control and gait stability. Affected arm swing movement and asymmetry during gait are common in neurological disorders such as Parkinson's disease (PD) even in early stages of the disease and arm swing treatment has been acknowledged to enhance gait and normalize arm swing in individuals with PD.
The presence of arm swing changes during walking in MS patients, similar to PD, especially in the early period, may be an indicator of balance problems, this was, however, not investigated as such. Therefore, the aim of the current study is to assess the arm swing during gait in people with MS shortly after their diagnosis in early MS.
- Being tested
- Evaluation of the arm swing during gait, Functional Tests
- Keywords
- arm swing, multiple sclerosis, gait, foot pressure analysis
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the arm swing during gaitOther
Also called Arm swing during walking
Evaluation of the arm swing during gait: The difference between the maximum flexion and extension of the shoulder is the arm swing amplitude during walking. The arm swing amplitude will be evaluated 2-dimensionally with the help of the Kinovea video player.
Functional TestsOther
Also called Two Minute Walk Test (2MWT), Timed Up and Go (TUG) and Timed 25Foot Walk Test (T25FW)
To understand the changes in functional mobility, Two Minute Walk Test (2MWT), Timed Up and Go (TUG) and Timed 25Foot Walk Test (T25FW) were conducted.
| Study group | Role | What they receive |
|---|---|---|
| Early Multiple Sclerosis | Arm swing evaluation and functional tests will be tested in this group. Receives: Other: Evaluation of the arm swing during gait; Other: Functional Tests | |
| Healthy Controls | Arm swing evaluation will be tested in this group. Receives: Other: Evaluation of the arm swing during gait |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm swing amplitude-shoulder degrees in flexion-extension direction
The difference between the maximum flexion and extension of the shoulder will be calculated with Kinovea video player.
Measured: 3 months after the baseline
Arm swing amplitude-elbow degrees in flexion-extension direction
The difference between the maximum flexion and extension of the shoulder will be calculated with Kinovea video player.
Measured: 3 months after the baseline
Arm swing amplitude-overall degrees in flexion-extension direction
The difference between the maximum flexion and extension of the shoulder will be calculated with Kinovea video player.
Measured: 3 months after the baseline
Step-speed
The stepping task required patients to walk back and forth for 2 minutes over a three meters walkway which was set up with the FreeMed foot pressure analysis system (Sensor Medica, Guidonia Montecelio). Step speed outcome was collected from foot pressure analysis system.
Measured: 3 months after the baseline
Two Minute Walk Test (2MWT)
It is a measure of self-paced walking ability and functional capacity. The person is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured.
Measured: 3 months after the baseline
Timed Up and Go (TUG)
To determine fall risk and measure the progress of balance, sit to stand and walking.It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Measured: 3 months after the baseline
Timed 25Foot Walk Test (T25FW)
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.
Measured: 3 months after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Dec 2021
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokce Leblebici, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821257
- Sponsor's protocol ID
- IstanbulUC_MStation_armswing
- Status last verified
- Jul 2023
- First submitted
- 27 Mar 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kalinowska-Lyszczarz A, Guo Y, Lucchinetti CF. Update on pathology of central nervous system inflammatory demyelinating diseases. Neurol Neurochir Pol. 2022;56(3):201-209. doi: 10.5603/PJNNS.a2022.0046. Epub 2022 Jun 27.
PubMed 35758517Morel E, Allali G, Laidet M, Assal F, Lalive PH, Armand S. Gait Profile Score in multiple sclerosis patients with low disability. Gait Posture. 2017 Jan;51:169-173. doi: 10.1016/j.gaitpost.2016.10.013. Epub 2016 Oct 18.
PubMed 27776271Meyns P, Bruijn SM, Duysens J. The how and why of arm swing during human walking. Gait Posture. 2013 Sep;38(4):555-62. doi: 10.1016/j.gaitpost.2013.02.006. Epub 2013 Mar 13.
PubMed 23489950Gholizadeh H, Hill A, Nantel J. The effect of various arm and walking conditions on postural dynamic stability when recovering from a trip perturbation. Gait Posture. 2020 Feb;76:284-289. doi: 10.1016/j.gaitpost.2019.11.010. Epub 2019 Dec 17.
PubMed 31884255Lewek MD, Poole R, Johnson J, Halawa O, Huang X. Arm swing magnitude and asymmetry during gait in the early stages of Parkinson's disease. Gait Posture. 2010 Feb;31(2):256-60. doi: 10.1016/j.gaitpost.2009.10.013. Epub 2009 Nov 27.
PubMed 19945285Koh SB, Park YM, Kim MJ, Kim WS. Influences of elbow, shoulder, trunk motion and temporospatial parameters on arm swing asymmetry of Parkinson's disease during walking. Hum Mov Sci. 2019 Dec;68:102527. doi: 10.1016/j.humov.2019.102527. Epub 2019 Nov 2.
PubMed 31689575Elsworth-Edelsten C, Bonnefoy-Mazure A, Laidet M, Armand S, Assal F, Lalive P, Allali G. Upper limb movement analysis during gait in multiple sclerosis patients. Hum Mov Sci. 2017 Aug;54:248-252. doi: 10.1016/j.humov.2017.05.014. Epub 2017 May 30.
PubMed 28575710Yoon J, Park J, Park K, Jo G, Kim H, Jang W, Kim JS, Youn J, Oh ES, Kim HT, Youm CH. The effects of additional arm weights on arm-swing magnitude and gait patterns in Parkinson's disease. Clin Neurophysiol. 2016 Jan;127(1):693-697. doi: 10.1016/j.clinph.2015.06.005. Epub 2015 Jun 15.
PubMed 26183756
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arm Swing During Walking in Early Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05821257
- Acronym / sponsor ID
- IstanbulUC_MStation_armswing
- Keywords
- arm swing, multiple sclerosis, gait, foot pressure analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Apr 2023 (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.
Multiple sclerosis (MS) is the most common central nervous system inflammatory demyelinating disease which causes motor and sensory deficits, cerebellar symptoms, and balance problems. Due to these symptoms, gait abnormalities are common in MS, even in patients with low degrees of impairment. The upper limb has an important role on postural control and gait stability. Affected arm swing movement and asymmetry during gait are common in neurological disorders such as Parkinson's disease (PD) even in early stages of the disease and arm swing treatment has been acknowledged to enhance gait and normalize arm swing in individuals with PD.
The presence of arm swing changes during walking in MS patients, similar to PD, especially in the early period, may be an indicator of balance problems, this was, however, not investigated as such. Therefore, the aim of the current study is to assess the arm swing during gait in people with MS shortly after their diagnosis in early MS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Multiple Sclerosis | – | Other: Evaluation of the arm swing during gait, Other: Functional TestsArm swing evaluation and functional tests will be tested in this group. |
| Healthy Controls | – | Other: Evaluation of the arm swing during gaitArm swing evaluation will be tested in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eighteen MS outpatients from a hospital and 10 healthy controls were included. The patients who were diagnosed with MS in the last 30 days, were recovered from their symptoms and were clinically stable were included. Patients who had an acute medical illness in the past 6 months, any other neurological and psychiatric diseases, and any orthopedic, rheumatologic, or vestibular conditions that affect walking were excluded. The patients who had exacerbations between the first and second evaluations (three months after the first evaluation) were excluded.
Key inclusion criteria (2 listed)
- Patients who were diagnosed with MS in the last 30 days,
- Patients who were recovered from their symptoms and were clinically stable
Key exclusion criteria (3 listed)
- Patients who had an acute medical illness in the past 6 months, any other neurological and psychiatric diseases
- Patients who had any orthopedic, rheumatologic, or vestibular conditions that affect walking
- Patients who had exacerbations between the first and second evaluations
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 |
|---|---|---|
| Evaluation of the arm swing during gaitAlso: Arm swing during walkingEvaluation of the arm swing during gait: The difference between the maximum flexion and extension of the shoulder is the arm swing amplitude during walking. The arm swing amplitude will be evaluated 2-dimensionally with the help of the Kinovea video player. | Other | Early Multiple Sclerosis, Healthy Controls |
| Functional TestsAlso: Two Minute Walk Test (2MWT), Timed Up and Go (TUG) and Timed 25Foot Walk Test (T25FW)To understand the changes in functional mobility, Two Minute Walk Test (2MWT), Timed Up and Go (TUG) and Timed 25Foot Walk Test (T25FW) were conducted. | Other | Early Multiple Sclerosis |
Primary outcome
Arm swing amplitude-shoulder degrees in flexion-extension direction
Time frame: 3 months after the baseline
The difference between the maximum flexion and extension of the shoulder will be calculated with Kinovea video player.
Arm swing amplitude-elbow degrees in flexion-extension direction
Time frame: 3 months after the baseline
The difference between the maximum flexion and extension of the shoulder will be calculated with Kinovea video player.
Arm swing amplitude-overall degrees in flexion-extension direction
Time frame: 3 months after the baseline
The difference between the maximum flexion and extension of the shoulder will be calculated with Kinovea video player.
Step-speed
Time frame: 3 months after the baseline
The stepping task required patients to walk back and forth for 2 minutes over a three meters walkway which was set up with the FreeMed foot pressure analysis system (Sensor Medica, Guidonia Montecelio). Step speed outcome was collected from foot pressure analysis system.
Two Minute Walk Test (2MWT)
Time frame: 3 months after the baseline
It is a measure of self-paced walking ability and functional capacity. The person is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured.
Timed Up and Go (TUG)
Time frame: 3 months after the baseline
To determine fall risk and measure the progress of balance, sit to stand and walking.It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Timed 25Foot Walk Test (T25FW)
Time frame: 3 months after the baseline
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.
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 27 Jul 2023.
- Background: PubMed 35758517Kalinowska-Lyszczarz A, Guo Y, Lucchinetti CF. Update on pathology of central nervous system inflammatory demyelinating diseases. Neurol Neurochir Pol. 2022;56(3):201-209. doi: 10.5603/PJNNS.a2022.0046. Epub 2022 Jun 27.
- Background: PubMed 27776271Morel E, Allali G, Laidet M, Assal F, Lalive PH, Armand S. Gait Profile Score in multiple sclerosis patients with low disability. Gait Posture. 2017 Jan;51:169-173. doi: 10.1016/j.gaitpost.2016.10.013. Epub 2016 Oct 18.
- Background: PubMed 23489950Meyns P, Bruijn SM, Duysens J. The how and why of arm swing during human walking. Gait Posture. 2013 Sep;38(4):555-62. doi: 10.1016/j.gaitpost.2013.02.006. Epub 2013 Mar 13.
- Background: PubMed 31884255Gholizadeh H, Hill A, Nantel J. The effect of various arm and walking conditions on postural dynamic stability when recovering from a trip perturbation. Gait Posture. 2020 Feb;76:284-289. doi: 10.1016/j.gaitpost.2019.11.010. Epub 2019 Dec 17.
- Background: PubMed 19945285Lewek MD, Poole R, Johnson J, Halawa O, Huang X. Arm swing magnitude and asymmetry during gait in the early stages of Parkinson's disease. Gait Posture. 2010 Feb;31(2):256-60. doi: 10.1016/j.gaitpost.2009.10.013. Epub 2009 Nov 27.
- Background: PubMed 31689575Koh SB, Park YM, Kim MJ, Kim WS. Influences of elbow, shoulder, trunk motion and temporospatial parameters on arm swing asymmetry of Parkinson's disease during walking. Hum Mov Sci. 2019 Dec;68:102527. doi: 10.1016/j.humov.2019.102527. Epub 2019 Nov 2.
- Background: PubMed 28575710Elsworth-Edelsten C, Bonnefoy-Mazure A, Laidet M, Armand S, Assal F, Lalive P, Allali G. Upper limb movement analysis during gait in multiple sclerosis patients. Hum Mov Sci. 2017 Aug;54:248-252. doi: 10.1016/j.humov.2017.05.014. Epub 2017 May 30.
- Background: PubMed 26183756Yoon J, Park J, Park K, Jo G, Kim H, Jang W, Kim JS, Youn J, Oh ES, Kim HT, Youm CH. The effects of additional arm weights on arm-swing magnitude and gait patterns in Parkinson's disease. Clin Neurophysiol. 2016 Jan;127(1):693-697. doi: 10.1016/j.clinph.2015.06.005. Epub 2015 Jun 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Upper Extremity Problem, run by Istanbul University - Cerrahpasa 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 3 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 27 Jul 2023. 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?
Arm swing amplitude-shoulder degrees in flexion-extension direction (time frame: 3 months after the baseline). The study lists 7 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 NCT05821257, which also lists 8 linked publications.
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 27 Jul 2023.