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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05821257
Other study ID # IstanbulUC_MStation_armswing
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date June 30, 2023

Study information

Verified date July 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date June 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients who were diagnosed with MS in the last 30 days, - Patients who were recovered from their symptoms and were clinically stable Exclusion Criteria: - 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

Study Design


Intervention

Other:
Evaluation of the arm swing during gait
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 Tests
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.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Elsworth-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. — View Citation

Gholizadeh 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. — View Citation

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. — View Citation

Koh 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. — View Citation

Lewek 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. — View Citation

Meyns 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. — View Citation

Morel 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. — View Citation

Yoon 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months after the baseline
Primary 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. 3 months after the baseline
Primary 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. 3 months after the baseline
Primary 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. 3 months after the baseline
Primary 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. 3 months after the baseline
Primary 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. 3 months after the baseline
Primary Timed 25Foot Walk Test (T25FW) The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. 3 months after the baseline
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