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Core Stability Training in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01414725
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
Jenny Freeman, University of Plymouth

Study Description
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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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Standard Physiotherapy Exercises Other: Core Stability Training Other: Relaxation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Core Stability Training in Ambulant Individuals With Multiple Sclerosis: a Multi-centre Randomised Controlled Trial.
Study Start Date : August 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Core Stability Training Other: 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.
Other Name: Physiotherapy
Placebo Comparator: Relaxation Other: 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.
Other Name: Physiotherapy
Active Comparator: Standard Physiotherapy Exercises 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.
Other Name: Physiotherapy


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414725


Locations
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United Kingdom
Merlin Centre, Bradbury House, Hewas water
St Austell, Cornwall, United Kingdom, PL26 7JF
Devon NHS Trust
Newton Abbot, Devon, United Kingdom, TQ12 2SL
University Of Plymouth, School of Health Professions
Plymouth, Devon, United Kingdom, PL6 9BH
Tavistock Community Hospital
Spring Hill, Tavistock, Devon, United Kingdom, PL19 8LD
Lanarkshire NHS Trust
Cumbernauld, North Lanarkshire, United Kingdom, G671BP
South Tees NHS Trust
Middlesborough, South Tees, United Kingdom, TS3BW
University College London Hospital Trust
London, United Kingdom, WC1 N3BG
Sponsors and Collaborators
University of Plymouth
Investigators
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Principal Investigator: Jennifer Freeman University of Plymouth
More Information
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Publications:
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

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Responsible Party: Jenny Freeman, Dr Jenny Freeman, University of Plymouth
ClinicalTrials.gov Identifier: NCT01414725    
Other Study ID Numbers: 10/H0106/88
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014
Keywords provided by Jenny Freeman, University of Plymouth:
Multiple Sclerosis
Mobility
Balance
Core Stability
Physiotherapy
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases