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Effects of Core Stability Training on Gait in Multiple Sclerosis Patients

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ClinicalTrials.gov Identifier: NCT03442049
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Baris Cetin, Hacettepe University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Gait Disorders, Neurologic Other: Physiotherapy - Study group Other: Physiotherapy - control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Core Stability Training in Patients With Multiple Sclerosis: Biomechanical and Performance Based Analysis of Gait
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : February 20, 2016
Actual Study Completion Date : May 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group
Spinal stabilization exercises in addition to home exercise program
Other: Physiotherapy - Study group
Study group : In addition to home program spinal stabilization exercises

Active Comparator: Control Group
Home exercise program
Other: Physiotherapy - control group
Home exercise program




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Publications:
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Responsible Party: Baris Cetin, Research Assisstant, Hacettepe University
ClinicalTrials.gov Identifier: NCT03442049     History of Changes
Other Study ID Numbers: GO 14/633
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baris Cetin, Hacettepe University:
Multiple Sclerosis
Gait
Spinal Stabilization Exercises
Plantar Pressure Distribution
Rehabilitation

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Gait Disorders, Neurologic
Nervous System Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Signs and Symptoms