Core Stability Training in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414725
• Other study ID #: 10/H0106/88
• Status: Completed
• Phase: N/A
• First received: August 5, 2011
• Last updated: March 21, 2014
• Start date: August 2011
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: University of Plymouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Lanarkshire NHS Trust	Cumbernauld	North Lanarkshire
United Kingdom	University College London Hospital Trust	London
United Kingdom	South Tees NHS Trust	Middlesborough	South Tees
United Kingdom	Devon NHS Trust	Newton Abbot	Devon
United Kingdom	University Of Plymouth, School of Health Professions	Plymouth	Devon
United Kingdom	Tavistock Community Hospital	Spring Hill, Tavistock	Devon
United Kingdom	Merlin Centre, Bradbury House, Hewas water	St Austell	Cornwall

Sponsors (1)

Lead Sponsor	Collaborator
University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Fox et al. (2013) Pilates based core stability training in ambulant individuals with multiple sclerosis: a multicentre, blinded, randomised, placebo controlled trial Way Ahead 2014;18(1):6-8 http://www.mstrust.org.uk/professionals/information/wayahead/articles/18012014_03.jsp

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 10 metre timed walk (10MTW)		baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Secondary	Change in Functional Reach - forwards and lateral		baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Secondary	Change in Visual Analogue Scale (10 point) to determine "Difficulty in carrying a drink when walking".		baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Secondary	Change in Activities-specific Balance Confidence (ABC) Scale		baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
Secondary	Change in Multiple Sclerosis 12-item Walking Scale		baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)