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Multiple SclerosisNCT02209467

Balance and Falls in Multiple Sclerosis

A study testing Group balance training in people with Multiple Sclerosis, run by Örebro County Council at 7 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study hypothesis is that for people with moderate to severe multiple sclerosis postural balance and walking improve and the risk of accidental falls are reduced after participating in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain a further 7 weeks post training. 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
52 participants
Where
7 sitesSweden
Study dates
Aug 2014to Aug 2015
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
  • Expanded Disability Scale Score of 5-6.5
  • walking speed of less than 0.8 m/s as tested on a 10 meter walking test

Who cannot join

  • Ongoing relapse
  • Cognitive or language difficulties that prohibit participating in the intervention or performing the outcome measures
  • Change in specific MS medication during the last 30 days

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Sweden7 sites

  • Neurorehab Mälarsjukhuset

    Eskilstuna

  • Physiotherapy department Gävle hospital

    Gävle

  • Rehab unit Karlskoga hospital

    Karlskoga

  • Primary Health Care

    Linköping

  • Nyköping hospital

    Nyköping

  • Physiotherapy department University hospital

    Örebro

  • Rehab unit Västerås hospital

    Västerås

Other trials in Sweden

About this study

Official title: Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins

The study hypothesis is that for people with moderate to severe multiple sclerosis postural balance and walking improve and the risk of accidental falls are reduced after participating in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain a further 7 weeks post training.

Multiple Sclerosis (MS) is disease affecting the central nervous system. Walking and postural balance are often affected early in the course of the disease. The risk of falls is large. Many persons with MS have decreased trunk stability compared to healthy persons . In an earlier study including people with mild to moderate MS we found that a period of core stability exercises reduced the risk of falls. In this study the training concept will be applied for persons with more severe walking limitations.

Being tested
Group balance training
Keywords
walking, postural balance, falls
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

    Group balance training 60 minutes 2 times per week plus 3-5 home exercises 2 times/week. Exercises focus om core stability in sitting, standing and lying.

Study groups in NCT02209467
Study groupRoleWhat they receive
Group balance training late startNo interventionParticipants randomized to late start act as No intervention group during the study period.
Group balance training early startExperimentalGroup balance training focusing on core stability exercises 2 times per week for 7 weeks and 2 home training sessions per weeks.
Receives: Other: Group balance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Berg Balance Scale at 8 weeks

    Measured: baseline, 8 weeks

Secondary outcomes (20)

  1. Change from baseline in 10 repetitions Sit to stand test at 15 weeks

    Measured: baseline, 15 weeks

  2. Change from baseline in Trunk Impairment scale at 8 weeks

    Measured: baseline, 8 weeks

  3. Change from baseline in the Trunk Impairment Scale at 15 weeks

    Measured: baseline, 15 weeks

  4. Change from baseline in the 10 repetition Si to stand test at 8 weeks

    Measured: baseline, 8 weeks

  5. Change from baseline in the Berg Balance scale at 15 weeks

    Measured: baseline, 15 weeks

  6. Change from baseline on the Timed Up and Go test at 8 weeks

    Measured: baseline, 8 weeks

  7. Change from baseline on the Timed Up and Go test at 15 weeks

    Measured: baseline, 15 weeks

  8. Change from baseline on the10 meter walking test at 8 weeks

    Measured: baseline, 8 weeks

  9. Change from baseline on the 10 meter walking test at 15 weks

    Measured: baseline, 15 weeks

  10. Change from baseline on the 2 minutes walking test at 8 weeks

    Measured: baseline, 8 weeks

  11. Change from baseline on the 2 minutes walking test at 15 weeks

    Measured: baseline, 15 weeks

  12. Change from baseline in postural sway at 8 weeks

    Measured: baseline, 8 weeks

  13. Change from baseline in postural sway at 15 weeks

    postural sway in standing on the floor is assessed

    Measured: baseline, 15 weeks

  14. Change from baseline on the Falls-Efficacy scale at 8 weeks

    Measured: baseline, 8 weeks

  15. Change from baseline on the Falls Efficacy scale at 15 weeks

    Measured: baseline, 15 weeks

  16. Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks

    Measured: baseline, 8 weeks

  17. Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks

    Measured: baseline, 15 weeks

  18. Change from baseline on the MS Walking Scale-12 at 8 weeks

    Measured: baseline, 8 weeks

  19. Change from baseline on the MS Walking scale-12 at 15 weeks

    Measured: baseline, 15 weeks

  20. The number of falls and accidental falls

    the number of falls and accidental falls are noted by the participant in a study-specific falls diary.

    Measured: from baseline to 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionMar 2015
  4. Study completionAug 2015

Resources

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
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02209467
Sponsor's protocol ID
Researchweb 153691
Status last verified
Oct 2015
First submitted
4 Aug 2014
Last updated
29 Oct 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

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 3 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 29 Oct 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 Berg Balance Scale at 8 weeks (time frame: baseline, 8 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 NCT02209467, 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 29 Oct 2015.

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