Core Stability Training in Multiple Sclerosis

Sponsor

University of Plymouth (Other)

Overall Status

Completed

CT.gov ID

NCT01414725

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

14.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Standard Physiotherapy Exercises Other: Core Stability Training Other: Relaxation	N/A

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

Study Type:

Interventional

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 :

Aug 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

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 Names: 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 Names: 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 Names: Physiotherapy

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 Names:

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 Names:

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 Names:

Physiotherapy

Outcome Measures

Primary Outcome Measures

Change in 10 metre timed walk (10MTW) [baseline (pre intervention), 12 weeks (immediately post intervention), 16 weeks ( one month follow-up)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merlin Centre, Bradbury House, Hewas water	St Austell	Cornwall	United Kingdom	PL26 7JF
2	Devon NHS Trust	Newton Abbot	Devon	United Kingdom	TQ12 2SL
3	University Of Plymouth, School of Health Professions	Plymouth	Devon	United Kingdom	PL6 9BH
4	Tavistock Community Hospital	Spring Hill, Tavistock	Devon	United Kingdom	PL19 8LD
5	Lanarkshire NHS Trust	Cumbernauld	North Lanarkshire	United Kingdom	G671BP
6	South Tees NHS Trust	Middlesborough	South Tees	United Kingdom	TS3BW
7	University College London Hospital Trust	London		United Kingdom	WC1 N3BG