Clinical trial NCT03442049: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Gait Disorders, Neurologic
Keywords: Multiple Sclerosis
Gait
Spinal Stabilization Exercises
Plantar Pressure Distribution
Rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 6 Minutes Walk Test
timeFrame: Change from Baseline 6 Minutes Walking Distance at 6 weeks.
measure: Modified Borg Scale
timeFrame: Change from Baseline Fatigue Score at 6 weeks.
measure: Plantar Pressure Distribution
timeFrame: Change from baseline peak pressure and contact area values at 6 weeks
measure: Plantar Pressure Distribution
timeFrame: Change from baseline peak pressure and contact area values at 6 weeks
measure: Multiple Sclerosis Quality of Life Scale
timeFrame: Change from baseline mental and physical quality of life scores at 6 weeks
Secondary outcomes:
measure: Muscle strength with hand held dynamometer
timeFrame: Change from baseline muscle strength at 6 weeks
measure: Muscle strength with hand held dynamometer
timeFrame: Change from baseline muscle strength at 6 weeks
measure: Muscle strength with hand held dynamometer
timeFrame: Change from baseline muscle strength at 6 weeks
measure: Muscle strength with hand held dynamometer
timeFrame: Change from baseline muscle strength at 6 weeks
measure: Muscle strength with hand held dynamometer
timeFrame: Change from baseline muscle strength at 6 weeks
measure: MiniBESTest
timeFrame: Change from baseline MiniBESTest scores at 6 weeks
measure: Dynamic Gait Index
timeFrame: Change from baseline Dynamic Gait Index scores at 6 weeks
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.