Multiple SclerosisNCT01582126
Group Balance Training for People With Multiple Sclerosis
A study testing Group balance training in people with Multiple Sclerosis, run by Örebro County Council at 7 sites in Sweden.
Trial summary
People with multiple sclerosis (MS) often have affected balance capacity and an increased risk for falls. A risk factor for falls are activities requiring dual attention. Another factor leading to reduced balance capacity is trunk stability, and decreased trunk stability has been seen in people with MS compared to… 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?
- Group balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 7 sitesSweden
- Study dates
- Aug 2012to 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
- Diagnosed multiple sclerosis by a neurologist, being able to walk 100 m with or without walking device, being able to get down on the floor with minor assistance
Who cannot join
- No balance deficit here defined as being able to stand still heel-toe for 30 seconds with arms crossed.
- Ongoing relapse, cognitive- or language difficulties that prohibits performing the outcome measures.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Mälarsjukhuset
Eskilstuna, 63188
Karlstad hospital
Karlstad
Rörelse och hälsa neuro
Linköping
Primärvård Mjölby
Mjölby
Nyköpings hospital
Nyköping
University Hospital Örebro
Örebro, 70185
Västerås hospital
Västerås, 72189
About this study
People with multiple sclerosis (MS) often have affected balance capacity and an increased risk for falls. A risk factor for falls are activities requiring dual attention. Another factor leading to reduced balance capacity is trunk stability, and decreased trunk stability has been seen in people with MS compared to healthy controls. Earlier studies using core stability exercises have shown positive effects on balance, compared to no training. In Sweden, physical therapy for people with MS has often included group training. However, evidence for this intervention is scarce. The aim of this study is therefore to investigate balance training in group. The balance training includes core stability exercises and dual attention activities. A multi-centre study is planned with a waiting-list design. Participants are randomised to either exercise group with early start or with late start. The group balance training includes training 60 minutes 2 times per week for 7 weeks.
- Conditions
- Multiple Sclerosis
- Being tested
- Group balance training
- Keywords
- multiple sclerosis, physical therapy, postural control
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group balance trainingOther
Balance training i group with focus on core stability exercises and dual attention activities.
| Study group | Role | What they receive |
|---|---|---|
| Group balance training early start | Experimental | Not described Receives: Other: Group balance training |
| Group balance training late start | Experimental | Not described Receives: Other: Group balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Bergs balance scale
Functional balance scale in sitting, standing and walking.
Measured: Change from Baseline in Bergs balance scale at 7 weeks
Secondary outcomes (15)
Change from Baseline in Four Square step test
Dynamic balance
Measured: Change from Baseline in Four Square step test at 7 weeks
Change from baseline in Timed chair stands test
Functional leg strength, rising 10 times from a chair.
Measured: Change from baseline in Times Chair stands test at 7 weeks
Change from baseline in Timed Up and Go test
Functional mobility.
Measured: Change from baseline in Timed Up and Go test at 7 weeks
Change from baseline in Functional Gait Assessment
Gait-related activities
Measured: Change from baseline in Functional Gait Assessment at 7 weeks
Change from baseline in Postural sway
Using a sway meter postural sway in standing still is assessed.
Measured: Change from baseline in Postural sway at 7 weeks
Change from baseline in Activities-specific Balance scale
16 item questionnaire that includes items on balance self-efficacy
Measured: Change from baseline in Activities-specific Balance scale at 7 weeks
Change from baseline in 12-item Multiple Sclerosis Walking scale
self-reported limitations in walking.
Measured: Change from baseline in 12-item Multiple Sclerosis Walking scale at 7 weeks
Change from Baseline in Bergs balance scale
Functional balance in sitting, standing and walking
Measured: Change from Baseline in Bergs balance scale at 14 weeks
Change from Baseline in Four Square step test
Dynamic balance
Measured: Change from baseline in Four Square step test at 14 weeks
Change from baseline in Times Chair stands test
Functional lower extremity strength
Measured: Change from baseline in Times Chair stands test at 14 weeks
Change from baseline in Timed Up and Go test
Functional mobility
Measured: Change from baseline in Timed Up and Go test at 14 weeks
Change from baseline in Functional Gait Assessment
Gait-related activities
Measured: Change from baseline in Functional Gait Assessment at 14 weeks
Change from baseline in postoral sway
Using a sway meter postural sway in standing still is assessed.
Measured: Change from baseline in postoral sway at 14 weeks
Change from baseline in Activities-specific Balance scale
Balance self-efficacy
Measured: Change from baseline in Activities-specific Balance scale at 14 weeks
Change from baseline in 12-item Multiple Sclerosis Walking scale
self-reported limitations in walking
Measured: Change from baseline in 12-item Multiple Sclerosis Walking scale at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startAug 2012
- 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 (1)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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Collaborators
- Uppsala-Örebro Regional Research Council, Norrbacka-Eugenia Foundation
- Responsible party
- Principal investigator, Anette Forsberg, PhD, Örebro County Council
- Investigators
- Anette Forsberg, PhD, Study chair, Family Medicine Research Centre, Örebro county councilYlva Nilsagård, PhD, Principal investigator, Centre for Health Care Sciences, Örebro county council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582126
- Sponsor's protocol ID
- Ö-1-12
- Status last verified
- Mar 2015
- First submitted
- 16 Apr 2012
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nilsagard YE, von Koch LK, Nilsson M, Forsberg AS. Balance exercise program reduced falls in people with multiple sclerosis: a single-group, pretest-posttest trial. Arch Phys Med Rehabil. 2014 Dec;95(12):2428-34. doi: 10.1016/j.apmr.2014.06.016. Epub 2014 Jul 6.
PubMed 25004466
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Balance Training for People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01582126
- Acronym / sponsor ID
- Ö-1-12
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, physical therapy, postural control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Collaborators
- Uppsala-Örebro Regional Research Council, Norrbacka-Eugenia Foundation
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Apr 2012 (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.
People with multiple sclerosis (MS) often have affected balance capacity and an increased risk for falls. A risk factor for falls are activities requiring dual attention. Another factor leading to reduced balance capacity is trunk stability, and decreased trunk stability has been seen in people with MS compared to healthy controls. Earlier studies using core stability exercises have shown positive effects on balance, compared to no training. In Sweden, physical therapy for people with MS has often included group training. However, evidence for this intervention is scarce. The aim of this study is therefore to investigate balance training in group. The balance training includes core stability exercises and dual attention activities. A multi-centre study is planned with a waiting-list design. Participants are randomised to either exercise group with early start or with late start. The group balance training includes training 60 minutes 2 times per week for 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group balance training early start | Experimental | Other: Group balance training |
| Group balance training late start | Experimental | Other: Group balance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed multiple sclerosis by a neurologist, being able to walk 100 m with or without walking device, being able to get down on the floor with minor assistance
Key exclusion criteria (2 listed)
- No balance deficit here defined as being able to stand still heel-toe for 30 seconds with arms crossed.
- Ongoing relapse, cognitive- or language difficulties that prohibits performing the outcome measures.
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 |
|---|---|---|
| Group balance trainingBalance training i group with focus on core stability exercises and dual attention activities. | Other | Group balance training early start, Group balance training late start |
Primary outcome
Change from Baseline in Bergs balance scale
Time frame: Change from Baseline in Bergs balance scale at 7 weeks
Functional balance scale in sitting, standing and walking.
15 secondary outcomes
Change from Baseline in Four Square step test
Time frame: Change from Baseline in Four Square step test at 7 weeks
Change from baseline in Timed chair stands test
Time frame: Change from baseline in Times Chair stands test at 7 weeks
Change from baseline in Timed Up and Go test
Time frame: Change from baseline in Timed Up and Go test at 7 weeks
Change from baseline in Functional Gait Assessment
Time frame: Change from baseline in Functional Gait Assessment at 7 weeks
Change from baseline in Postural sway
Time frame: Change from baseline in Postural sway at 7 weeks
Change from baseline in Activities-specific Balance scale
Time frame: Change from baseline in Activities-specific Balance scale at 7 weeks
Change from baseline in 12-item Multiple Sclerosis Walking scale
Time frame: Change from baseline in 12-item Multiple Sclerosis Walking scale at 7 weeks
Change from Baseline in Bergs balance scale
Time frame: Change from Baseline in Bergs balance scale at 14 weeks
Change from Baseline in Four Square step test
Time frame: Change from baseline in Four Square step test at 14 weeks
Change from baseline in Times Chair stands test
Time frame: Change from baseline in Times Chair stands test at 14 weeks
Change from baseline in Timed Up and Go test
Time frame: Change from baseline in Timed Up and Go test at 14 weeks
Change from baseline in Functional Gait Assessment
Time frame: Change from baseline in Functional Gait Assessment at 14 weeks
Change from baseline in postoral sway
Time frame: Change from baseline in postoral sway at 14 weeks
Change from baseline in Activities-specific Balance scale
Time frame: Change from baseline in Activities-specific Balance scale at 14 weeks
Change from baseline in 12-item Multiple Sclerosis Walking scale
Time frame: Change from baseline in 12-item Multiple Sclerosis Walking scale at 14 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 27 Mar 2015.
- Derived from this study: PubMed 25004466Nilsagard YE, von Koch LK, Nilsson M, Forsberg AS. Balance exercise program reduced falls in people with multiple sclerosis: a single-group, pretest-posttest trial. Arch Phys Med Rehabil. 2014 Dec;95(12):2428-34. doi: 10.1016/j.apmr.2014.06.016. Epub 2014 Jul 6.
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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.
Anette Forsberg, PhD study chair
Family Medicine Research Centre, Örebro county council
Ylva Nilsagård, PhD principal investigator
Centre for Health Care Sciences, Örebro county council
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group balance training in people with Multiple Sclerosis, run by Örebro County Council at 7 sites in Sweden.
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 1 inclusion and 2 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 27 Mar 2015. 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 Sweden. 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. 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 from Baseline in Bergs balance scale (time frame: Change from Baseline in Bergs balance scale at 7 weeks). 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 NCT01582126, which also lists 1 linked publication.
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 27 Mar 2015.