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Completed

NCT Number: NCT02209467

Balance and Falls in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurorehab Mälarsjukhuset, Eskilstuna, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

group balance training

Other

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.

Primary outcomes

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

    Time frame: baseline, 8 weeks

Secondary outcomes

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

    Time frame: baseline, 15 weeks

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

    Time frame: baseline, 8 weeks

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

    Time frame: baseline, 15 weeks

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

    Time frame: baseline, 8 weeks

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

    Time frame: baseline, 15 weeks

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

    Time frame: baseline, 8 weeks

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

    Time frame: baseline, 15 weeks

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

    Time frame: baseline, 8 weeks

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

    Time frame: baseline, 15 weeks

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

    Time frame: baseline, 8 weeks

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

    Time frame: baseline, 15 weeks

  12. Change from baseline in postural sway at 8 weeks

    Time frame: baseline, 8 weeks

  13. Change from baseline in postural sway at 15 weeks

    Time frame: baseline, 15 weeks

    postural sway in standing on the floor is assessed

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

    Time frame: baseline, 8 weeks

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

    Time frame: baseline, 15 weeks

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

    Time frame: baseline, 8 weeks

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

    Time frame: baseline, 15 weeks

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

    Time frame: baseline, 8 weeks

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

    Time frame: baseline, 15 weeks

  20. The number of falls and accidental falls

    Time frame: from baseline to 15 weeks

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

Sponsors and collaborators

Lead sponsor

Örebro County Council

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2014
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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