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Effects of Core Stability Training on Gait in Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiotherapy - Study group
Physiotherapy - control group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Gait, Spinal Stabilization Exercises, Plantar Pressure Distribution, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Study group

    Control Group

    Arm Description

    Spinal stabilization exercises in addition to home exercise program

    Home exercise program

    Outcomes

    Primary Outcome Measures

    6 Minutes Walk Test
    Maximum Walking Distance in 6 Minutes
    Modified Borg Scale
    Evaluating fatigue between the scores of 0 and 10. "0" means no fatigue at all. "10" means maximal fatigue.
    Plantar Pressure Distribution
    Peak pressure values of 10 subregions under the foot
    Plantar Pressure Distribution
    Contact area values of 10 subregions under the foot
    Multiple Sclerosis Quality of Life Scale
    Quality of life assessment with 54 questions about mental and physical health in daily life activities.

    Secondary Outcome Measures

    Muscle strength with hand held dynamometer
    Hip Flexors Muscle Strength
    Muscle strength with hand held dynamometer
    Hip Abductors Muscle Strength
    Muscle strength with hand held dynamometer
    Knee Flexors Muscle Strength
    Muscle strength with hand held dynamometer
    Knee Extensors Muscle Strength
    Muscle strength with hand held dynamometer
    Ankle Dorsiflexors Muscle Strength
    MiniBESTest
    Static and dynamic balance evaluation. This test includes 14 items and maximum score is 28. 28 points means best balance status.
    Dynamic Gait Index
    Dynamic balance evaluation especially walking balance. This test includes 8 items and maximum score is 24. Maximum score means best dynamic balance status.

    Full Information

    First Posted
    January 25, 2018
    Last Updated
    February 15, 2018
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03442049
    Brief Title
    Effects of Core Stability Training on Gait in Multiple Sclerosis Patients
    Official Title
    Randomized Controlled Trial of Core Stability Training in Patients With Multiple Sclerosis: Biomechanical and Performance Based Analysis of Gait
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    February 20, 2016 (Actual)
    Study Completion Date
    May 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Gait Disorders, Neurologic
    Keywords
    Multiple Sclerosis, Gait, Spinal Stabilization Exercises, Plantar Pressure Distribution, Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Controlled Trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    Spinal stabilization exercises in addition to home exercise program
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Home exercise program
    Intervention Type
    Other
    Intervention Name(s)
    Physiotherapy - Study group
    Intervention Description
    Study group : In addition to home program spinal stabilization exercises
    Intervention Type
    Other
    Intervention Name(s)
    Physiotherapy - control group
    Intervention Description
    Home exercise program
    Primary Outcome Measure Information:
    Title
    6 Minutes Walk Test
    Description
    Maximum Walking Distance in 6 Minutes
    Time Frame
    Change from Baseline 6 Minutes Walking Distance at 6 weeks.
    Title
    Modified Borg Scale
    Description
    Evaluating fatigue between the scores of 0 and 10. "0" means no fatigue at all. "10" means maximal fatigue.
    Time Frame
    Change from Baseline Fatigue Score at 6 weeks.
    Title
    Plantar Pressure Distribution
    Description
    Peak pressure values of 10 subregions under the foot
    Time Frame
    Change from baseline peak pressure and contact area values at 6 weeks
    Title
    Plantar Pressure Distribution
    Description
    Contact area values of 10 subregions under the foot
    Time Frame
    Change from baseline peak pressure and contact area values at 6 weeks
    Title
    Multiple Sclerosis Quality of Life Scale
    Description
    Quality of life assessment with 54 questions about mental and physical health in daily life activities.
    Time Frame
    Change from baseline mental and physical quality of life scores at 6 weeks
    Secondary Outcome Measure Information:
    Title
    Muscle strength with hand held dynamometer
    Description
    Hip Flexors Muscle Strength
    Time Frame
    Change from baseline muscle strength at 6 weeks
    Title
    Muscle strength with hand held dynamometer
    Description
    Hip Abductors Muscle Strength
    Time Frame
    Change from baseline muscle strength at 6 weeks
    Title
    Muscle strength with hand held dynamometer
    Description
    Knee Flexors Muscle Strength
    Time Frame
    Change from baseline muscle strength at 6 weeks
    Title
    Muscle strength with hand held dynamometer
    Description
    Knee Extensors Muscle Strength
    Time Frame
    Change from baseline muscle strength at 6 weeks
    Title
    Muscle strength with hand held dynamometer
    Description
    Ankle Dorsiflexors Muscle Strength
    Time Frame
    Change from baseline muscle strength at 6 weeks
    Title
    MiniBESTest
    Description
    Static and dynamic balance evaluation. This test includes 14 items and maximum score is 28. 28 points means best balance status.
    Time Frame
    Change from baseline MiniBESTest scores at 6 weeks
    Title
    Dynamic Gait Index
    Description
    Dynamic balance evaluation especially walking balance. This test includes 8 items and maximum score is 24. Maximum score means best dynamic balance status.
    Time Frame
    Change from baseline Dynamic Gait Index scores at 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23917098
    Citation
    Bethoux F. Gait disorders in multiple sclerosis. Continuum (Minneap Minn). 2013 Aug;19(4 Multiple Sclerosis):1007-22. doi: 10.1212/01.CON.0000433286.92596.d5.
    Results Reference
    background
    PubMed Identifier
    18951800
    Citation
    Givon U, Zeilig G, Achiron A. Gait analysis in multiple sclerosis: characterization of temporal-spatial parameters using GAITRite functional ambulation system. Gait Posture. 2009 Jan;29(1):138-42. doi: 10.1016/j.gaitpost.2008.07.011. Epub 2008 Oct 31.
    Results Reference
    background
    PubMed Identifier
    20699285
    Citation
    Freeman JA, Gear M, Pauli A, Cowan P, Finnigan C, Hunter H, Mobberley C, Nock A, Sims R, Thain J. The effect of core stability training on balance and mobility in ambulant individuals with multiple sclerosis: a multi-centre series of single case studies. Mult Scler. 2010 Nov;16(11):1377-84. doi: 10.1177/1352458510378126. Epub 2010 Aug 10.
    Results Reference
    background
    PubMed Identifier
    16540858
    Citation
    Hides J, Wilson S, Stanton W, McMahon S, Keto H, McMahon K, Bryant M, Richardson C. An MRI investigation into the function of the transversus abdominis muscle during "drawing-in" of the abdominal wall. Spine (Phila Pa 1976). 2006 Mar 15;31(6):E175-8. doi: 10.1097/01.brs.0000202740.86338.df.
    Results Reference
    background
    PubMed Identifier
    22480437
    Citation
    Freeman J, Fox E, Gear M, Hough A. Pilates based core stability training in ambulant individuals with multiple sclerosis: protocol for a multi-centre randomised controlled trial. BMC Neurol. 2012 Apr 5;12:19. doi: 10.1186/1471-2377-12-19.
    Results Reference
    background

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    Effects of Core Stability Training on Gait in Multiple Sclerosis Patients

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