Core Stability Training in Multiple Sclerosis
This study is currently recruiting participants.
Verified March 2013 by University of Plymouth
Sponsor:
University of Plymouth
Information provided by (Responsible Party):
Jenny Freeman, University of Plymouth
ClinicalTrials.gov Identifier:
NCT01414725
First received: August 5, 2011
Last updated: March 15, 2013
Last verified: March 2013
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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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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
Contacts
| Contact: Jennifer Freeman | 01752 588835 | jenny.freeman@plymouth.ac.uk |
| Contact: Esther Fox | 01752 588888 | esther.fox@plymouth.ac.uk |
Locations
| United Kingdom | |
| Merlin Centre, Bradbury House, Hewas water | Completed |
| St Austell, Cornwall, United Kingdom, PL26 7JF | |
| Devon NHS Trust | Completed |
| Newton Abbot, Devon, United Kingdom, TQ12 2SL | |
| University Of Plymouth, School of Health Professions | Recruiting |
| Plymouth, Devon, United Kingdom, PL6 9BH | |
| Contact: Esther Fox 01752 588888 esther.fox@plymouth.ac.uk | |
| Contact: Jennifer Freeman 01752 588835 jenny.freeman@plymouth.ac.uk | |
| Sub-Investigator: Esther Fox | |
| Principal Investigator: Jennifer Freeman | |
| Tavistock Community Hospital | Completed |
| Spring Hill, Tavistock, Devon, United Kingdom, PL19 8LD | |
| Lanarkshire NHS Trust | Completed |
| Cumbernauld, North Lanarkshire, United Kingdom, G671BP | |
| South Tees NHS Trust | Completed |
| Middlesborough, South Tees, United Kingdom, TS3BW | |
| University College London Hospital Trust | Completed |
| 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 15, 2013 |
| 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 May 16, 2013