Effects of Core Stability Training on Gait in Multiple Sclerosis Patients

February 15, 2018 updated by: Baris Cetin, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Spinal stabilization exercises in addition to home exercise program
Other: Physiotherapy - Study group
Study group : In addition to home program spinal stabilization exercises
Active Comparator: Control Group
Home exercise program
Other: Physiotherapy - control group
Home exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minutes Walk Test
Time Frame: Change from Baseline 6 Minutes Walking Distance at 6 weeks.
Maximum Walking Distance in 6 Minutes
Change from Baseline 6 Minutes Walking Distance at 6 weeks.
Modified Borg Scale
Time Frame: Change from Baseline Fatigue Score at 6 weeks.
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
Time Frame: Change from baseline peak pressure and contact area values at 6 weeks
Peak pressure values of 10 subregions under the foot
Change from baseline peak pressure and contact area values at 6 weeks
Plantar Pressure Distribution
Time Frame: Change from baseline peak pressure and contact area values at 6 weeks
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
Time Frame: Change from baseline mental and physical quality of life scores at 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength with hand held dynamometer
Time Frame: Change from baseline muscle strength at 6 weeks
Hip Flexors Muscle Strength
Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Time Frame: Change from baseline muscle strength at 6 weeks
Hip Abductors Muscle Strength
Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Time Frame: Change from baseline muscle strength at 6 weeks
Knee Flexors Muscle Strength
Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Time Frame: Change from baseline muscle strength at 6 weeks
Knee Extensors Muscle Strength
Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Time Frame: Change from baseline muscle strength at 6 weeks
Ankle Dorsiflexors Muscle Strength
Change from baseline muscle strength at 6 weeks
MiniBESTest
Time Frame: Change from baseline MiniBESTest scores at 6 weeks
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
Dynamic Gait Index
Time Frame: Change from baseline Dynamic Gait Index scores at 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

February 20, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 14/633

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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