Multiple SclerosisNCT03442049
Effects of Core Stability Training on Gait in Multiple Sclerosis Patients
A study testing Physiotherapy - Study group in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by Hacettepe University.
Trial summary
Gait and mobility are among the functions frequently affected in Multiple Sclerosis (MS) and have a negative impact on quality of life. Strength losses in lower limb muscles, ataxia, sensory problems and fatigue are the most important reasons of walking problems in patients with MS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Gait Disorders, Neurologic
- What is being tested?
- Physiotherapy - Study group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 May 2016
- 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
- Older than 18 years old
- EDSS score is between 3-5,5
- Patients who did not take corticosteroid therapy within three months
- Patients who get at least 24 points from the Mini Mental Test were included in the study.
Who cannot join
- Patients who had an acute MS attack or had an attack within the last three months.
- An orthopedic or systemic problem that would prevent participation in exercises
- Patients who were using walking orthoses or walking aids were not included in the study.
About this study
Official title: Randomized Controlled Trial of Core Stability Training in Patients With Multiple Sclerosis: Biomechanical and Performance Based Analysis of Gait
Gait and mobility are among the functions frequently affected in Multiple Sclerosis (MS) and have a negative impact on quality of life. Strength losses in lower limb muscles, ataxia, sensory problems and fatigue are the most important reasons of walking problems in patients with MS. In addition to loss of strength and tonus problems, especially biomechanical disorders can be seen on foot and this problem affects gatin and balance negatively. The stabilizing muscles, defined as the "core" region and enveloping the body like a corset, are active in the context of postural preparation prior to lower extremity movements and stabilize for the limb movements to be performed. The aim of this study was to investigate the effects of spinal stabilization exercises on walking performance, fatigue, plantar pressure distribution, balance, muscle strength and quality of life in patients with Multiple Sclerosis.
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Being tested
- Physiotherapy - Study group, Physiotherapy - control group
- Keywords
- Multiple Sclerosis, Gait, Spinal Stabilization Exercises, Plantar Pressure Distribution, Rehabilitation
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy - Study groupOther
Study group : In addition to home program spinal stabilization exercises
Physiotherapy - control groupOther
Home exercise program
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Spinal stabilization exercises in addition to home exercise program Receives: Other: Physiotherapy - Study group |
| Control Group | Active comparator | Home exercise program Receives: Other: Physiotherapy - control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes Walk Test
Maximum Walking Distance in 6 Minutes
Measured: Change from Baseline 6 Minutes Walking Distance at 6 weeks.
Modified Borg Scale
Evaluating fatigue between the scores of 0 and 10. "0" means no fatigue at all. "10" means maximal fatigue.
Measured: Change from Baseline Fatigue Score at 6 weeks.
Plantar Pressure Distribution
Peak pressure values of 10 subregions under the foot
Measured: Change from baseline peak pressure and contact area values at 6 weeks
Plantar Pressure Distribution
Contact area values of 10 subregions under the foot
Measured: Change from baseline peak pressure and contact area values at 6 weeks
Multiple Sclerosis Quality of Life Scale
Quality of life assessment with 54 questions about mental and physical health in daily life activities.
Measured: Change from baseline mental and physical quality of life scores at 6 weeks
Secondary outcomes (7)
Muscle strength with hand held dynamometer
Hip Flexors Muscle Strength
Measured: Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Hip Abductors Muscle Strength
Measured: Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Knee Flexors Muscle Strength
Measured: Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Knee Extensors Muscle Strength
Measured: Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Ankle Dorsiflexors Muscle Strength
Measured: Change from baseline muscle strength at 6 weeks
MiniBESTest
Static and dynamic balance evaluation. This test includes 14 items and maximum score is 28. 28 points means best balance status.
Measured: Change from baseline MiniBESTest scores at 6 weeks
Dynamic Gait Index
Dynamic balance evaluation especially walking balance. This test includes 8 items and maximum score is 24. Maximum score means best dynamic balance status.
Measured: Change from baseline Dynamic Gait Index scores at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jan 2015
- Primary completion20 Feb 2016
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baris Cetin, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442049
- Sponsor's protocol ID
- GO 14/633
- Status last verified
- Feb 2018
- First submitted
- 25 Jan 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bethoux F. Gait disorders in multiple sclerosis. Continuum (Minneap Minn). 2013 Aug;19(4 Multiple Sclerosis):1007-22. doi: 10.1212/01.CON.0000433286.92596.d5.
PubMed 23917098Givon U, Zeilig G, Achiron A. Gait analysis in multiple sclerosis: characterization of temporal-spatial parameters using GAITRite functional ambulation system. Gait Posture. 2009 Jan;29(1):138-42. doi: 10.1016/j.gaitpost.2008.07.011. Epub 2008 Oct 31.
PubMed 18951800Freeman 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 20699285Hides J, Wilson S, Stanton W, McMahon S, Keto H, McMahon K, Bryant M, Richardson C. An MRI investigation into the function of the transversus abdominis muscle during "drawing-in" of the abdominal wall. Spine (Phila Pa 1976). 2006 Mar 15;31(6):E175-8. doi: 10.1097/01.brs.0000202740.86338.df.
PubMed 16540858Freeman 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 22480437
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Core Stability Training in Patients With Multiple Sclerosis: Biomechanical and Performance Based Analysis of Gait
- ClinicalTrials.gov ID
- NCT03442049
- Acronym / sponsor ID
- GO 14/633
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Keywords
- Multiple Sclerosis, Gait, Spinal Stabilization Exercises, Plantar Pressure Distribution, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 20 Feb 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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.
Gait and mobility are among the functions frequently affected in Multiple Sclerosis (MS) and have a negative impact on quality of life. Strength losses in lower limb muscles, ataxia, sensory problems and fatigue are the most important reasons of walking problems in patients with MS. In addition to loss of strength and tonus problems, especially biomechanical disorders can be seen on foot and this problem affects gatin and balance negatively. The stabilizing muscles, defined as the "core" region and enveloping the body like a corset, are active in the context of postural preparation prior to lower extremity movements and stabilize for the limb movements to be performed. The aim of this study was to investigate the effects of spinal stabilization exercises on walking performance, fatigue, plantar pressure distribution, balance, muscle strength and quality of life in patients with Multiple Sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Physiotherapy - Study groupSpinal stabilization exercises in addition to home exercise program |
| Control Group | Active comparator | Other: Physiotherapy - control groupHome exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years old
- EDSS score is between 3-5,5
- Patients who did not take corticosteroid therapy within three months
- Patients who get at least 24 points from the Mini Mental Test were included in the study.
Key exclusion criteria (3 listed)
- Patients who had an acute MS attack or had an attack within the last three months.
- An orthopedic or systemic problem that would prevent participation in exercises
- Patients who were using walking orthoses or walking aids were not included in the 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 |
|---|---|---|
| Physiotherapy - Study groupStudy group : In addition to home program spinal stabilization exercises | Other | Study group |
| Physiotherapy - control groupHome exercise program | Other | Control Group |
Primary outcome
6 Minutes Walk Test
Time frame: Change from Baseline 6 Minutes Walking Distance at 6 weeks.
Maximum Walking Distance in 6 Minutes
Modified Borg Scale
Time frame: Change from Baseline Fatigue Score at 6 weeks.
Evaluating fatigue between the scores of 0 and 10. "0" means no fatigue at all. "10" means maximal fatigue.
Plantar Pressure Distribution
Time frame: Change from baseline peak pressure and contact area values at 6 weeks
Peak pressure values of 10 subregions under the foot
Plantar Pressure Distribution
Time frame: Change from baseline peak pressure and contact area values at 6 weeks
Contact area values of 10 subregions under the foot
Multiple Sclerosis Quality of Life Scale
Time frame: Change from baseline mental and physical quality of life scores at 6 weeks
Quality of life assessment with 54 questions about mental and physical health in daily life activities.
7 secondary outcomes
Muscle strength with hand held dynamometer
Time frame: Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Time frame: Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Time frame: Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Time frame: Change from baseline muscle strength at 6 weeks
Muscle strength with hand held dynamometer
Time frame: Change from baseline muscle strength at 6 weeks
MiniBESTest
Time frame: Change from baseline MiniBESTest scores at 6 weeks
Dynamic Gait Index
Time frame: Change from baseline Dynamic Gait Index scores at 6 weeks
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 22 Feb 2018.
- Background: PubMed 23917098Bethoux F. Gait disorders in multiple sclerosis. Continuum (Minneap Minn). 2013 Aug;19(4 Multiple Sclerosis):1007-22. doi: 10.1212/01.CON.0000433286.92596.d5.
- Background: PubMed 18951800Givon U, Zeilig G, Achiron A. Gait analysis in multiple sclerosis: characterization of temporal-spatial parameters using GAITRite functional ambulation system. Gait Posture. 2009 Jan;29(1):138-42. doi: 10.1016/j.gaitpost.2008.07.011. Epub 2008 Oct 31.
- 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 16540858Hides J, Wilson S, Stanton W, McMahon S, Keto H, McMahon K, Bryant M, Richardson C. An MRI investigation into the function of the transversus abdominis muscle during "drawing-in" of the abdominal wall. Spine (Phila Pa 1976). 2006 Mar 15;31(6):E175-8. doi: 10.1097/01.brs.0000202740.86338.df.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy - Study group in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by Hacettepe University.
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 4 inclusion and 3 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
6 Minutes Walk Test (time frame: Change from Baseline 6 Minutes Walking Distance at 6 weeks.). The study lists 5 primary outcomes in all. 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 NCT03442049, which also lists 5 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 22 Feb 2018.