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
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
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
NCT ID
NCT03442049
First Posted
January 25, 2018
Last Updated
February 15, 2018
Sponsor
Hacettepe University
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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