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Balance and Falls in Multiple Sclerosis

Not Applicable
Completed
Conditions
Multiple Sclerosis
Interventions
Other: Group balance training
Registration Number
NCT02209467
Lead Sponsor
Örebro County Council
Brief 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.

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
52
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Group balance training early startGroup balance trainingGroup balance training focusing on core stability exercises 2 times per week for 7 weeks and 2 home training sessions per weeks.
Primary Outcome Measures
NameTimeMethod
Change from baseline in Berg Balance Scale at 8 weeksbaseline, 8 weeks
Secondary Outcome Measures
NameTimeMethod
Change from baseline in 10 repetitions Sit to stand test at 15 weeksbaseline, 15 weeks
Change from baseline in Trunk Impairment scale at 8 weeksbaseline, 8 weeks
Change from baseline in the Trunk Impairment Scale at 15 weeksbaseline, 15 weeks
Change from baseline in the 10 repetition Si to stand test at 8 weeksbaseline, 8 weeks
Change from baseline in the Berg Balance scale at 15 weeksbaseline, 15 weeks
Change from baseline on the Timed Up and Go test at 8 weeksbaseline, 8 weeks
Change from baseline on the Timed Up and Go test at 15 weeksbaseline, 15 weeks
Change from baseline on the10 meter walking test at 8 weeksbaseline, 8 weeks
Change from baseline on the 10 meter walking test at 15 weksbaseline, 15 weeks
Change from baseline on the 2 minutes walking test at 8 weeksbaseline, 8 weeks
Change from baseline on the 2 minutes walking test at 15 weeksbaseline, 15 weeks
Change from baseline in postural sway at 8 weeksbaseline, 8 weeks
Change from baseline in postural sway at 15 weeksbaseline, 15 weeks

postural sway in standing on the floor is assessed

Change from baseline on the Falls-Efficacy scale at 8 weeksbaseline, 8 weeks
Change from baseline on the Falls Efficacy scale at 15 weeksbaseline, 15 weeks
Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeksbaseline, 8 weeks
Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeksbaseline, 15 weeks
Change from baseline on the MS Walking Scale-12 at 8 weeksbaseline, 8 weeks
Change from baseline on the MS Walking scale-12 at 15 weeksbaseline, 15 weeks
The number of falls and accidental fallsfrom baseline to 15 weeks

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

Trial Locations

Locations (7)

Physiotherapy department Gävle hospital

🇸🇪

Gävle, Sweden

Rehab unit Karlskoga hospital

🇸🇪

Karlskoga, Sweden

Primary Health Care

🇸🇪

Linköping, Sweden

Neurorehab Mälarsjukhuset

🇸🇪

Eskilstuna, Sweden

Nyköping hospital

🇸🇪

Nyköping, Sweden

Rehab unit Västerås hospital

🇸🇪

Västerås, Sweden

Physiotherapy department University hospital

🇸🇪

Örebro, Sweden

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