NCT05821257

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

March 27, 2023

Last Update Submit

July 26, 2023

Conditions

Keywords

arm swing, multiple sclerosis, gait, foot pressure analysis

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Early Multiple Sclerosis

Arm swing evaluation and functional tests will be tested in this group.

Other: Evaluation of the arm swing during gaitOther: Functional Tests

Healthy Controls

Arm swing evaluation will be tested in this group.

Other: Evaluation of the arm swing during gait

Interventions

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.

Also known as: Arm swing during walking
Early Multiple SclerosisHealthy Controls

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.

Also known as: Two Minute Walk Test (2MWT), Timed Up and Go (TUG) and Timed 25Foot Walk Test (T25FW)
Early Multiple Sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients who were diagnosed with MS in the last 30 days,
  • Patients who were recovered from their symptoms and were clinically stable

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 35758517BACKGROUND
  • 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.

    PMID: 27776271BACKGROUND
  • 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.

    PMID: 23489950BACKGROUND
  • 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.

    PMID: 31884255BACKGROUND
  • 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.

    PMID: 19945285BACKGROUND
  • 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.

    PMID: 31689575BACKGROUND
  • 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.

    PMID: 28575710BACKGROUND
  • 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.

    PMID: 26183756BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 20, 2023

Study Start

December 1, 2021

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations