Core Stability Training in Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Standard Physiotherapy Exercises
* Other: Core Stability Training
* Other: Relaxation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Core Stability Training<br> | Other: Core Stability Training<br>* 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.<br>* Other names: Physiotherapy;|
| Placebo Comparator: Relaxation<br> | Other: Relaxation<br>* 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.<br>* Other names: Physiotherapy;|
| Active Comparator: Standard Physiotherapy Exercises<br> | Other: Standard Physiotherapy Exercises<br>* 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.<br>* Other names: Physiotherapy;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Reach - forwards and lateral |  | 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 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Mobility, Balance, Core Stability, Physiotherapy