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Clinical Trials/NCT02209467
NCT02209467
Completed
Not Applicable

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

Örebro County Council7 sites in 1 country52 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Örebro County Council
Enrollment
52
Locations
7
Primary Endpoint
Change from baseline in Berg Balance Scale at 8 weeks
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Örebro County Council
Responsible Party
Principal Investigator
Principal Investigator

Anette Forsberg, PhD

PhD, lecturer

Örebro County Council

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline in Berg Balance Scale at 8 weeks

Time Frame: baseline, 8 weeks

Secondary Outcomes

  • Change from baseline on the Falls-Efficacy scale at 8 weeks(baseline, 8 weeks)
  • Change from baseline in 10 repetitions Sit to stand test at 15 weeks(baseline, 15 weeks)
  • Change from baseline in Trunk Impairment scale at 8 weeks(baseline, 8 weeks)
  • Change from baseline in the Trunk Impairment Scale at 15 weeks(baseline, 15 weeks)
  • Change from baseline in the 10 repetition Si to stand test at 8 weeks(baseline, 8 weeks)
  • Change from baseline in the Berg Balance scale at 15 weeks(baseline, 15 weeks)
  • Change from baseline on the Timed Up and Go test at 8 weeks(baseline, 8 weeks)
  • Change from baseline on the Timed Up and Go test at 15 weeks(baseline, 15 weeks)
  • Change from baseline on the10 meter walking test at 8 weeks(baseline, 8 weeks)
  • Change from baseline on the 10 meter walking test at 15 weks(baseline, 15 weeks)
  • Change from baseline on the 2 minutes walking test at 8 weeks(baseline, 8 weeks)
  • Change from baseline on the 2 minutes walking test at 15 weeks(baseline, 15 weeks)
  • Change from baseline in postural sway at 8 weeks(baseline, 8 weeks)
  • Change from baseline in postural sway at 15 weeks(baseline, 15 weeks)
  • Change from baseline on the Falls Efficacy scale at 15 weeks(baseline, 15 weeks)
  • Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks(baseline, 8 weeks)
  • Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks(baseline, 15 weeks)
  • Change from baseline on the MS Walking Scale-12 at 8 weeks(baseline, 8 weeks)
  • Change from baseline on the MS Walking scale-12 at 15 weeks(baseline, 15 weeks)
  • The number of falls and accidental falls(from baseline to 15 weeks)

Study Sites (7)

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