Effects of Core Stability Training on Gait in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442049
• Other study ID #: GO 14/633
• Status: Completed
• Phase: N/A
• First received: January 25, 2018
• Last updated: February 15, 2018
• Start date: January 1, 2015
• Est. completion date: May 1, 2016

Study information

• Verified date: February 2018
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 1, 2016
• Est. primary completion date: February 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Multiple Sclerosis
• Nervous System Diseases
• Sclerosis

Intervention

Other:
• Physiotherapy - Study group
Study group : In addition to home program spinal stabilization exercises
• Physiotherapy - control group
Home exercise program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minutes Walk Test	Maximum Walking Distance in 6 Minutes	Change from Baseline 6 Minutes Walking Distance at 6 weeks.
Primary	Modified Borg Scale	Evaluating fatigue between the scores of 0 and 10. "0" means no fatigue at all. "10" means maximal fatigue.	Change from Baseline Fatigue Score at 6 weeks.
Primary	Plantar Pressure Distribution	Peak pressure values of 10 subregions under the foot	Change from baseline peak pressure and contact area values at 6 weeks
Primary	Plantar Pressure Distribution	Contact area values of 10 subregions under the foot	Change from baseline peak pressure and contact area values at 6 weeks
Primary	Multiple Sclerosis Quality of Life Scale	Quality of life assessment with 54 questions about mental and physical health in daily life activities.	Change from baseline mental and physical quality of life scores at 6 weeks
Secondary	Muscle strength with hand held dynamometer	Hip Flexors Muscle Strength	Change from baseline muscle strength at 6 weeks
Secondary	Muscle strength with hand held dynamometer	Hip Abductors Muscle Strength	Change from baseline muscle strength at 6 weeks
Secondary	Muscle strength with hand held dynamometer	Knee Flexors Muscle Strength	Change from baseline muscle strength at 6 weeks
Secondary	Muscle strength with hand held dynamometer	Knee Extensors Muscle Strength	Change from baseline muscle strength at 6 weeks
Secondary	Muscle strength with hand held dynamometer	Ankle Dorsiflexors Muscle Strength	Change from baseline muscle strength at 6 weeks
Secondary	MiniBESTest	Static and dynamic balance evaluation. This test includes 14 items and maximum score is 28. 28 points means best balance status.	Change from baseline MiniBESTest scores at 6 weeks
Secondary	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.	Change from baseline Dynamic Gait Index scores at 6 weeks