Core Stability Training in Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jenny Freeman, University of Plymouth
ClinicalTrials.gov Identifier:
NCT01414725
First received: August 5, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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 Intervention
Multiple Sclerosis
Other: Standard Physiotherapy Exercises
Other: Core Stability Training
Other: Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Core Stability Training in Ambulant Individuals With Multiple Sclerosis: a Multi-centre Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Plymouth:

Primary Outcome Measures:
  • Change in 10 metre timed walk (10MTW) [ Time Frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Functional Reach - forwards and lateral [ Time Frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Change in Activities-specific Balance Confidence (ABC) Scale [ Time Frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up) ] [ Designated as safety issue: No ]
  • Change in Multiple Sclerosis 12-item Walking Scale [ Time Frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up) ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414725

Locations
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
Principal Investigator: Jennifer Freeman University of Plymouth
  More Information

Additional Information:
Publications:
Responsible Party: Jenny Freeman, Dr Jenny Freeman, University of Plymouth
ClinicalTrials.gov Identifier: NCT01414725     History of Changes
Other Study ID Numbers: 10/H0106/88
Study First Received: August 5, 2011
Last Updated: March 21, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Plymouth:
Multiple Sclerosis
Mobility
Balance
Core Stability
Physiotherapy

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 21, 2014