Multiple SclerosisNCT01414725
Core Stability Training in Multiple Sclerosis
A study testing Standard Physiotherapy Exercises, Core Stability Training and Relaxation in people with Multiple Sclerosis, run by University of Plymouth at 7 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Standard Physiotherapy Exercises, Core Stability Training and Relaxation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Aug 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Lanarkshire NHS Trust
Cumbernauld, North Lanarkshire, G671BP
University College London Hospital Trust
London, WC1 N3BG
South Tees NHS Trust
Middlesbrough, South Tees, TS3BW
Devon NHS Trust
Newton Abbot, Devon, TQ12 2SL
University Of Plymouth, School of Health Professions
Plymouth, Devon, PL6 9BH
Tavistock Community Hospital
Spring Hill, Tavistock, Devon, PL19 8LD
Merlin Centre, Bradbury House, Hewas water
St Austell, Cornwall, PL26 7JF
About this study
Official title: Core Stability Training in Ambulant Individuals With Multiple Sclerosis: a Multi-centre Randomised Controlled Trial.
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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Standard Physiotherapy Exercises, Core Stability Training, Relaxation
- Keywords
- Multiple Sclerosis, Mobility, Balance, Core Stability, Physiotherapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physiotherapy ExercisesOther
Also called Physiotherapy
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.
Core Stability TrainingOther
Also called Physiotherapy
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.
RelaxationOther
Also called Physiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Core Stability Training | Experimental | Not described Receives: Other: Core Stability Training |
| Relaxation | Placebo comparator | Not described Receives: Other: Relaxation |
| Standard Physiotherapy Exercises | Active comparator | Not described Receives: Other: Standard Physiotherapy Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10 metre timed walk (10MTW)
Measured: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Secondary outcomes (4)
Change in Functional Reach - forwards and lateral
Measured: 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".
Measured: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Change in Activities-specific Balance Confidence (ABC) Scale
Measured: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
Change in Multiple Sclerosis 12-item Walking Scale
Measured: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Freeman, University of Plymouth
- Investigators
- Jennifer Freeman, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414725
- Sponsor's protocol ID
- 10/H0106/88
- Status last verified
- Mar 2014
- First submitted
- 5 Aug 2011
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20699285Freeman 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.
PubMed 22480437Fox 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Stability Training in Ambulant Individuals With Multiple Sclerosis: a Multi-centre Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01414725
- Acronym / sponsor ID
- 10/H0106/88
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Mobility, Balance, Core Stability, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core Stability Training | Experimental | Other: Core Stability Training |
| Relaxation | Placebo comparator | Other: Relaxation |
| Standard Physiotherapy Exercises | Active comparator | Other: Standard Physiotherapy Exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Physiotherapy ExercisesAlso: PhysiotherapyIndividualised 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 | Standard Physiotherapy Exercises |
| Core Stability TrainingAlso: PhysiotherapyIndividualised 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 | Core Stability Training |
| RelaxationAlso: PhysiotherapyThree 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 | Relaxation |
Primary outcome
Change in 10 metre timed walk (10MTW)
Time frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
4 secondary outcomes
Change in Functional Reach - forwards and lateral
Time frame: 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".
Time frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)
Change in Activities-specific Balance Confidence (ABC) Scale
Time frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
Change in Multiple Sclerosis 12-item Walking Scale
Time frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks (one month follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Background: PubMed 20699285Freeman 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.
- Background: PubMed 22480437Freeman 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.
- BackgroundFox 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Freeman principal investigator
University of Plymouth
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Physiotherapy Exercises, Core Stability Training and Relaxation in people with Multiple Sclerosis, run by University of Plymouth at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10 metre timed walk (10MTW) (time frame: baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414725, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014; AzTrials last refreshed its copy on 4 Nov 2026.