Effects of Core Stability Training on Gait in Multiple Sclerosis Patients

NCT03442049 | Completed

• 1 other identifier: GO 14/633
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic

Keywords

Multiple Sclerosis; Gait; Spinal Stabilization Exercises; Plantar Pressure Distribution; Rehabilitation

Outcome Measures

Primary Outcomes (5)

• 6 Minutes Walk Test

  Maximum Walking Distance in 6 Minutes

  Change from Baseline 6 Minutes Walking Distance at 6 weeks.

• 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.

• Plantar Pressure Distribution

  Peak pressure values of 10 subregions under the foot

  Change from baseline peak pressure and contact area values at 6 weeks

• Plantar Pressure Distribution

  Contact area values of 10 subregions under the foot

  Change from baseline peak pressure and contact area values at 6 weeks

• 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 Outcomes (7)

• Muscle strength with hand held dynamometer

  Change from baseline muscle strength at 6 weeks

• Muscle strength with hand held dynamometer

  Change from baseline muscle strength at 6 weeks

• Muscle strength with hand held dynamometer

  Change from baseline muscle strength at 6 weeks

• Muscle strength with hand held dynamometer

  Change from baseline muscle strength at 6 weeks

• Muscle strength with hand held dynamometer

  Change from baseline muscle strength at 6 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Spinal stabilization exercises in addition to home exercise program

Other: Physiotherapy - Study group

Control Group

ACTIVE COMPARATOR

Home exercise program

Other: Physiotherapy - control group

Interventions

Physiotherapy - Study group OTHER

Study group : In addition to home program spinal stabilization exercises

Study group

Physiotherapy - control group OTHER

Home exercise program

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Related 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.

  PMID: 23917098 BACKGROUND

• 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.

  PMID: 18951800 BACKGROUND

• 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.

  PMID: 20699285 BACKGROUND

• 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.

  PMID: 16540858 BACKGROUND

• 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.

  PMID: 22480437 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assisstant

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 22, 2018
• Study Start: January 1, 2015
• Primary Completion: February 20, 2016
• Study Completion: May 1, 2016
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share