Core Stability Training in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Standard Physiotherapy Exercises; Other: Relaxation; Other: Core Stability Training

• Registration Number: NCT01414725
• Lead Sponsor: University of Plymouth

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard Physiotherapy Exercises	Standard Physiotherapy Exercises	-
Relaxation	Relaxation	-
Core Stability Training	Core Stability Training	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Activities-specific Balance Confidence (ABC) Scale	baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
Change in Multiple Sclerosis 12-item Walking Scale	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".	baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Change in Functional Reach - forwards and lateral	baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)

Trial Locations

Locations (7)

Devon NHS Trust; 🇬🇧 Newton Abbot, Devon, United Kingdom

Tavistock Community Hospital; 🇬🇧 Spring Hill, Tavistock, Devon, United Kingdom

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

University Of Plymouth, School of Health Professions; 🇬🇧 Plymouth, Devon, United Kingdom

Lanarkshire NHS Trust; 🇬🇧 Cumbernauld, North Lanarkshire, United Kingdom

South Tees NHS Trust; 🇬🇧 Middlesborough, South Tees, United Kingdom

University College London Hospital Trust; 🇬🇧 London, United Kingdom