Skip to main content
OpenTrials
Completed

NCT Number: NCT01414725

Core Stability Training in Multiple Sclerosis

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Merlin Centre, Bradbury House, Hewas water, St Austell, Cornwall, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Physiotherapy Exercises

Other

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

Core stability training

Other

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

relaxation

Other

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

Primary outcomes

  1. Change in 10 metre timed walk (10MTW)

    Time frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)

Secondary outcomes

  1. Change in Functional Reach - forwards and lateral

    Time frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)

  2. 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)

  3. Change in Activities-specific Balance Confidence (ABC) Scale

    Time frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)

  4. Change in Multiple Sclerosis 12-item Walking Scale

    Time frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)

Sponsors and collaborators

Lead sponsor

University of Plymouth

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2011
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.