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CompletedNCT03442049Updated Feb 22, 2018

Effects of Core Stability Training on Gait in Multiple Sclerosis Patients

An interventional study of Physiotherapy - Study group and Physiotherapy - control group in Multiple Sclerosis and Gait Disorders, Neurologic, sponsored by Hacettepe University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis
  • Gait Disorders, Neurologic

Keywords

  • Multiple Sclerosis
  • Gait
  • Spinal Stabilization Exercises
  • Plantar Pressure Distribution
  • Rehabilitation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Study group

    Spinal stabilization exercises in addition to home exercise program

    Other: Physiotherapy - Study group

  • Active comparator
    Control Group

    Home exercise program

    Other: Physiotherapy - control group

Interventions

  • OtherPhysiotherapy - Study group

    Study group : In addition to home program spinal stabilization exercises

  • OtherPhysiotherapy - control group

    Home exercise program

05

What researchers measure

Primary outcomes

  1. 6 Minutes Walk Test

    Maximum Walking Distance in 6 Minutes

    Time frame: Change from Baseline 6 Minutes Walking Distance at 6 weeks.

  2. Modified Borg Scale

    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.

  3. Plantar Pressure Distribution

    Peak pressure values of 10 subregions under the foot

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

  4. Plantar Pressure Distribution

    Contact area values of 10 subregions under the foot

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

  5. Multiple Sclerosis Quality of Life Scale

    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 outcomes

  1. Muscle strength with hand held dynamometer

    Hip Flexors Muscle Strength

    Time frame: Change from baseline muscle strength at 6 weeks

  2. Muscle strength with hand held dynamometer

    Hip Abductors Muscle Strength

    Time frame: Change from baseline muscle strength at 6 weeks

  3. Muscle strength with hand held dynamometer

    Knee Flexors Muscle Strength

    Time frame: Change from baseline muscle strength at 6 weeks

  4. Muscle strength with hand held dynamometer

    Knee Extensors Muscle Strength

    Time frame: Change from baseline muscle strength at 6 weeks

  5. Muscle strength with hand held dynamometer

    Ankle Dorsiflexors Muscle Strength

    Time frame: Change from baseline muscle strength at 6 weeks

  6. MiniBESTest

    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

  7. 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.

    Time frame: Change from baseline Dynamic Gait Index scores at 6 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 23917098 ↗
  • 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. PubMed 18951800 ↗
  • 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. PubMed 20699285 ↗
  • 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. PubMed 16540858 ↗
  • 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. PubMed 22480437 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03442049
Lead sponsor
Hacettepe University
Responsible party
Baris Cetin (Research Assisstant, Hacettepe University) — Principal investigator
First posted
Feb 22, 2018
Start date
Jan 1, 2015
Primary completion
Feb 20, 2016
Completion
May 1, 2016
Last update
Feb 22, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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