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Balance and Falls in Multiple Sclerosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02209467
Enrollment
52
Registered
2014-08-06
Start date
2014-08-31
Completion date
2015-08-31
Last updated
2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

walking, postural balance, falls

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.

Interventions

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.

Sponsors

Örebro County Council
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in Berg Balance Scale at 8 weeksbaseline, 8 weeks

Secondary

MeasureTime frameDescription
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 in 10 repetitions Sit to stand 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 weekspostural 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 weeksthe number of falls and accidental falls are noted by the participant in a study-specific falls diary.
Change from baseline on the 2 minutes walking test at 15 weeksbaseline, 15 weeks

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026