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Completed

NCT Number: NCT01582126

Group Balance Training for People With Multiple Sclerosis

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.

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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

Mälarsjukhuset, Eskilstuna, Sweden

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

group balance training

Other

Balance training i group with focus on core stability exercises and dual attention activities.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change from Baseline in Four Square step test

    Time frame: Change from Baseline in Four Square step test at 7 weeks

    Dynamic balance

  2. Change from baseline in Timed chair stands test

    Time frame: Change from baseline in Times Chair stands test at 7 weeks

    Functional leg strength, rising 10 times from a chair.

  3. Change from baseline in Timed Up and Go test

    Time frame: Change from baseline in Timed Up and Go test at 7 weeks

    Functional mobility.

  4. Change from baseline in Functional Gait Assessment

    Time frame: Change from baseline in Functional Gait Assessment at 7 weeks

    Gait-related activities

  5. Change from baseline in Postural sway

    Time frame: Change from baseline in Postural sway at 7 weeks

    Using a sway meter postural sway in standing still is assessed.

  6. Change from baseline in Activities-specific Balance scale

    Time frame: Change from baseline in Activities-specific Balance scale at 7 weeks

    16 item questionnaire that includes items on balance self-efficacy

  7. 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

    self-reported limitations in walking.

  8. Change from Baseline in Bergs balance scale

    Time frame: Change from Baseline in Bergs balance scale at 14 weeks

    Functional balance in sitting, standing and walking

  9. Change from Baseline in Four Square step test

    Time frame: Change from baseline in Four Square step test at 14 weeks

    Dynamic balance

  10. Change from baseline in Times Chair stands test

    Time frame: Change from baseline in Times Chair stands test at 14 weeks

    Functional lower extremity strength

  11. Change from baseline in Timed Up and Go test

    Time frame: Change from baseline in Timed Up and Go test at 14 weeks

    Functional mobility

  12. Change from baseline in Functional Gait Assessment

    Time frame: Change from baseline in Functional Gait Assessment at 14 weeks

    Gait-related activities

  13. Change from baseline in postoral sway

    Time frame: Change from baseline in postoral sway at 14 weeks

    Using a sway meter postural sway in standing still is assessed.

  14. Change from baseline in Activities-specific Balance scale

    Time frame: Change from baseline in Activities-specific Balance scale at 14 weeks

    Balance self-efficacy

  15. 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

    self-reported limitations in walking

Sponsors and collaborators

Lead sponsor

Örebro County Council

Other Gov

Collaborators

  • Norrbacka-Eugenia Foundation
  • Uppsala-Örebro Regional Research Council

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 20, 2012
Registry last updated
Mar 27, 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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