Core Stability Training in Multiple Sclerosis

March 21, 2014 updated by: Jenny Freeman, University of Plymouth

Core Stability Training in Ambulant Individuals With Multiple Sclerosis: a Multi-centre Randomised Controlled Trial.

The primary purpose of this study is to determine whether a 12 week Pilates based core stability training programme is effective in improving balance, mobility and balance confidence in ambulant individuals with Multiple Sclerosis (MS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of this study is to determine whether a 12 week Pilates based core stability training programme is effective in improving balance, mobility and balance confidence in ambulant individuals with Multiple Sclerosis (MS). The secondary aim is to determine the relative effectiveness of this 12 week Pilates based core stability training programme compared to a standardised physiotherapy exercise programme. Finally we intend to explore the underlying mechanisms of change associated with these exercise interventions by directly measuring changes in muscle thickness and activation in the deep abdominal core stabilising muscles of a sub-set of participants.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1 N3BG
        • University College London Hospital Trust
    • Cornwall
      • St Austell, Cornwall, United Kingdom, PL26 7JF
        • Merlin Centre, Bradbury House, Hewas water
    • Devon
      • Newton Abbot, Devon, United Kingdom, TQ12 2SL
        • Devon NHS Trust
      • Plymouth, Devon, United Kingdom, PL6 9BH
        • University Of Plymouth, School of Health Professions
      • Spring Hill, Tavistock, Devon, United Kingdom, PL19 8LD
        • Tavistock Community Hospital
    • North Lanarkshire
      • Cumbernauld, North Lanarkshire, United Kingdom, G671BP
        • Lanarkshire NHS Trust
    • South Tees
      • Middlesborough, South Tees, United Kingdom, TS3BW
        • South Tees NHS Trust

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:

  • Definite diagnosis of MS, according to McDonald's criteria
  • Aged 18 years or over
  • Able to walk independently with or without use of intermittent or constant unilateral assistance such as walking stick or orthotic brace

Exclusion Criteria:

  • In relapse or relapse in previous three months
  • Any medical condition contra-indicating participation in core stability exercises
  • Score < 6 on the Abbreviated Mental Test, as an indicator of those whose cognitive difficulties could interfere with the informed consent process, or the ability to fully engage in the exercise programme.
  • Current or recent (within past 6 months) participation in core stability exercises
  • Current involvement in another interventional research 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: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Core Stability Training
Other: Core Stability Training
Individualised face to face training sessions, delivered over 12 weeks, plus an individualised 15-minute daily home exercise programme will be provided. This will be undertaken by a neurological physiotherapist with experience in the delivery of core stability training to people with MS. Exercises will be progressed in response to the abilities of the individual. Each participant will receive a workbook with written and diagrammatic instructions describing their home exercise programme.
Other Names:
  • Physiotherapy
Placebo Comparator: Relaxation
Other: Relaxation
Three face to face individualised relaxation sessions, provided at 4 weekly intervals, plus a 15-minute home programme based around an audio relaxation CD. Weekly telephone contact / support will be provided.
Other Names:
  • Physiotherapy
Active Comparator: Standard Physiotherapy Exercises
Other: Standard Physiotherapy Exercises
Individualised face to face training sessions, delivered over 12 weeks, plus an individualised 15-minute daily home exercise programme will be provided. This will be undertaken by a neurological physiotherapist. The exercises will comprise a standardised programme of simple physiotherapy exercises which aim to improve trunk and pelvic stability, lower limb muscle length and strength, and balance and control of movement, as described by Barrett et al [2009]. Exercises will be progressed in response to the abilities of the individual. Each participant will receive a workbook with written and diagrammatic instructions describing their home exercise programme.
Other Names:
  • Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 10 metre timed walk (10MTW)
Time Frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Functional Reach - forwards and lateral
Time Frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Change in Visual Analogue Scale (10 point) to determine "Difficulty in carrying a drink when walking".
Time Frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Change in Activities-specific Balance Confidence (ABC) Scale
Time Frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
Change in Multiple Sclerosis 12-item Walking Scale
Time Frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)

Collaborators and Investigators

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

Sponsor

University of Plymouth

Investigators

  • Principal Investigator: Jennifer Freeman, University of Plymouth

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

August 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/H0106/88

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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