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NCT Number: NCT05821257

Arm Swing During Walking in Early Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Gait Disorders, Neurologic Immune System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Problem

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of the arm swing during gait

Other

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.

Other names: Arm swing during walking

functional tests

Other

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 names: Two Minute Walk Test (2MWT), Timed Up and Go (TUG) and Timed 25Foot Walk Test (T25FW)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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