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Completed

NCT Number: NCT03442049

Effects of Core Stability Training on Gait in Multiple Sclerosis Patients

Gait and mobility are among the functions frequently affected in Multiple Sclerosis (MS) and have a negative impact on quality of life. Strength losses in lower limb muscles, ataxia, sensory problems and fatigue are the most important reasons of walking problems in patients with MS. In addition to loss of strength and tonus problems, especially biomechanical disorders can be seen on foot and this problem affects gatin and balance negatively. The stabilizing muscles, defined as the "core" region and enveloping the body like a corset, are active in the context of postural preparation prior to lower extremity movements and stabilize for the limb movements to be performed. The aim of this study was to investigate the effects of spinal stabilization exercises on walking performance, fatigue, plantar pressure distribution, balance, muscle strength and quality of life in patients with Multiple Sclerosis.

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Older than 18 years old
  • EDSS score is between 3-5,5
  • Patients who did not take corticosteroid therapy within three months
  • Patients who get at least 24 points from the Mini Mental Test were included in the study.

Exclusion criteria

  • Patients who had an acute MS attack or had an attack within the last three months.
  • An orthopedic or systemic problem that would prevent participation in exercises
  • Patients who were using walking orthoses or walking aids were not included in the study.

Treatment and study plan

Physiotherapy - Study group

Other

Study group : In addition to home program spinal stabilization exercises

Physiotherapy - control group

Other

Home exercise program

Primary outcomes

  1. 6 Minutes Walk Test

    Time frame: Change from Baseline 6 Minutes Walking Distance at 6 weeks.

    Maximum Walking Distance in 6 Minutes

  2. Modified Borg Scale

    Time frame: Change from Baseline Fatigue Score at 6 weeks.

    Evaluating fatigue between the scores of 0 and 10. "0" means no fatigue at all. "10" means maximal fatigue.

  3. Plantar Pressure Distribution

    Time frame: Change from baseline peak pressure and contact area values at 6 weeks

    Peak pressure values of 10 subregions under the foot

  4. Plantar Pressure Distribution

    Time frame: Change from baseline peak pressure and contact area values at 6 weeks

    Contact area values of 10 subregions under the foot

  5. Multiple Sclerosis Quality of Life Scale

    Time frame: Change from baseline mental and physical quality of life scores at 6 weeks

    Quality of life assessment with 54 questions about mental and physical health in daily life activities.

Secondary outcomes

  1. Muscle strength with hand held dynamometer

    Time frame: Change from baseline muscle strength at 6 weeks

    Hip Flexors Muscle Strength

  2. Muscle strength with hand held dynamometer

    Time frame: Change from baseline muscle strength at 6 weeks

    Hip Abductors Muscle Strength

  3. Muscle strength with hand held dynamometer

    Time frame: Change from baseline muscle strength at 6 weeks

    Knee Flexors Muscle Strength

  4. Muscle strength with hand held dynamometer

    Time frame: Change from baseline muscle strength at 6 weeks

    Knee Extensors Muscle Strength

  5. Muscle strength with hand held dynamometer

    Time frame: Change from baseline muscle strength at 6 weeks

    Ankle Dorsiflexors Muscle Strength

  6. MiniBESTest

    Time frame: Change from baseline MiniBESTest scores at 6 weeks

    Static and dynamic balance evaluation. This test includes 14 items and maximum score is 28. 28 points means best balance status.

  7. Dynamic Gait Index

    Time frame: Change from baseline Dynamic Gait Index scores at 6 weeks

    Dynamic balance evaluation especially walking balance. This test includes 8 items and maximum score is 24. Maximum score means best dynamic balance status.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Randomized Controlled Trial of Core Stability Training in Patients With Multiple Sclerosis: Biomechanical and Performance Based Analysis of Gait

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2018
Registry last updated
Feb 22, 2018

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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