Clinical trial NCT01414725: Core Stability Training in Multiple Sclerosis
Official title: Core Stability Training in Ambulant Individuals With Multiple Sclerosis: a Multi-centre Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Mobility
Balance
Core Stability
Physiotherapy
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 10 metre timed walk (10MTW)
timeFrame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Secondary outcomes:
measure: Change in Functional Reach - forwards and lateral
timeFrame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
measure: Change in Visual Analogue Scale (10 point) to determine "Difficulty in carrying a drink when walking".
timeFrame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
measure: Change in Activities-specific Balance Confidence (ABC) Scale
timeFrame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
measure: Change in Multiple Sclerosis 12-item Walking Scale
timeFrame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
Other outcomes:
Locations:
city: St Austell
country: United Kingdom
facility: Merlin Centre, Bradbury House, Hewas water
state: Cornwall
city: Newton Abbot
country: United Kingdom
facility: Devon NHS Trust
state: Devon
city: Plymouth
country: United Kingdom
facility: University Of Plymouth, School of Health Professions
state: Devon
city: Spring Hill, Tavistock
country: United Kingdom
facility: Tavistock Community Hospital
state: Devon
city: Cumbernauld
country: United Kingdom
facility: Lanarkshire NHS Trust
state: North Lanarkshire
city: Middlesborough
country: United Kingdom
facility: South Tees NHS Trust
state: South Tees
city: London
country: United Kingdom
facility: University College London Hospital Trust
Study officials:
affiliation: University of Plymouth
name: Jennifer Freeman
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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