NCT01414725

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

1.9 years

First QC Date

August 5, 2011

Last Update Submit

March 21, 2014

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisMobilityBalanceCore StabilityPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Change in 10 metre timed walk (10MTW)

    baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)

Secondary Outcomes (4)

  • 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)

Study Arms (3)

Core Stability Training

EXPERIMENTAL
Other: Core Stability Training

Relaxation

PLACEBO COMPARATOR
Other: Relaxation

Standard Physiotherapy Exercises

ACTIVE COMPARATOR
Other: Standard Physiotherapy Exercises

Interventions

Standard Physiotherapy ExercisesOTHER

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.

Also known as: Physiotherapy
Standard Physiotherapy Exercises
Core Stability TrainingOTHER

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.

Also known as: Physiotherapy
Core Stability Training
RelaxationOTHER

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.

Also known as: Physiotherapy
Relaxation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Merlin Centre, Bradbury House, Hewas water

St Austell, Cornwall, PL26 7JF, United Kingdom

Location

Devon NHS Trust

Newton Abbot, Devon, TQ12 2SL, United Kingdom

Location

University Of Plymouth, School of Health Professions

Plymouth, Devon, PL6 9BH, United Kingdom

Location

Tavistock Community Hospital

Spring Hill, Tavistock, Devon, PL19 8LD, United Kingdom

Location

Lanarkshire NHS Trust

Cumbernauld, North Lanarkshire, G671BP, United Kingdom

Location

South Tees NHS Trust

Middlesbrough, South Tees, TS3BW, United Kingdom

Location

University College London Hospital Trust

London, WC1 N3BG, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 20699285BACKGROUND

  • 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.

    PMID: 22480437BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Jennifer Freeman

    University of Plymouth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Jenny Freeman

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 11, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations

GB(7)