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Core Stability Training in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Standard Physiotherapy Exercises
Core Stability Training
Relaxation
Sponsored by
University of Plymouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Mobility, Balance, Core Stability, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Merlin Centre, Bradbury House, Hewas water
  • Devon NHS Trust
  • University Of Plymouth, School of Health Professions
  • Tavistock Community Hospital
  • Lanarkshire NHS Trust
  • South Tees NHS Trust
  • University College London Hospital Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Core Stability Training

Relaxation

Standard Physiotherapy Exercises

Arm Description

Outcomes

Primary Outcome Measures

Change in 10 metre timed walk (10MTW)

Secondary Outcome Measures

Change in Functional Reach - forwards and lateral
Change in Visual Analogue Scale (10 point) to determine "Difficulty in carrying a drink when walking".
Change in Activities-specific Balance Confidence (ABC) Scale
Change in Multiple Sclerosis 12-item Walking Scale

Full Information

First Posted
August 5, 2011
Last Updated
March 21, 2014
Sponsor
University of Plymouth
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1. Study Identification

Unique Protocol Identification Number
NCT01414725
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Mobility, Balance, Core Stability, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Core Stability Training
Arm Type
Experimental
Arm Title
Relaxation
Arm Type
Placebo Comparator
Arm Title
Standard Physiotherapy Exercises
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Standard Physiotherapy Exercises
Other Intervention Name(s)
Physiotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Core Stability Training
Other Intervention Name(s)
Physiotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Relaxation
Other Intervention Name(s)
Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in Functional Reach - forwards and lateral
Time Frame
baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Title
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)
Title
Change in Activities-specific Balance Confidence (ABC) Scale
Time Frame
baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
Title
Change in Multiple Sclerosis 12-item Walking Scale
Time Frame
baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Freeman
Organizational Affiliation
University of Plymouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Merlin Centre, Bradbury House, Hewas water
City
St Austell
State/Province
Cornwall
ZIP/Postal Code
PL26 7JF
Country
United Kingdom
Facility Name
Devon NHS Trust
City
Newton Abbot
State/Province
Devon
ZIP/Postal Code
TQ12 2SL
Country
United Kingdom
Facility Name
University Of Plymouth, School of Health Professions
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 9BH
Country
United Kingdom
Facility Name
Tavistock Community Hospital
City
Spring Hill, Tavistock
State/Province
Devon
ZIP/Postal Code
PL19 8LD
Country
United Kingdom
Facility Name
Lanarkshire NHS Trust
City
Cumbernauld
State/Province
North Lanarkshire
ZIP/Postal Code
G671BP
Country
United Kingdom
Facility Name
South Tees NHS Trust
City
Middlesborough
State/Province
South Tees
ZIP/Postal Code
TS3BW
Country
United Kingdom
Facility Name
University College London Hospital Trust
City
London
ZIP/Postal Code
WC1 N3BG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20699285
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.
Results Reference
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PubMed Identifier
22480437
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.
Results Reference
background
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
Results Reference
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Core Stability Training in Multiple Sclerosis

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