Clinical trial NCT02209467: Balance and Falls in Multiple Sclerosis
Official title: Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: walking
postural balance
falls
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
First posted: 2014-08-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in Berg Balance Scale at 8 weeks
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change from baseline in 10 repetitions Sit to stand test at 15 weeks
timeFrame: baseline, 15 weeks
measure: Change from baseline in Trunk Impairment scale at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline in the Trunk Impairment Scale at 15 weeks
timeFrame: baseline, 15 weeks
measure: Change from baseline in the 10 repetition Si to stand test at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline in the Berg Balance scale at 15 weeks
timeFrame: baseline, 15 weeks
measure: Change from baseline on the Timed Up and Go test at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline on the Timed Up and Go test at 15 weeks
timeFrame: baseline, 15 weeks
measure: Change from baseline on the10 meter walking test at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline on the 10 meter walking test at 15 weks
timeFrame: baseline, 15 weeks
measure: Change from baseline on the 2 minutes walking test at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline on the 2 minutes walking test at 15 weeks
timeFrame: baseline, 15 weeks
measure: Change from baseline in postural sway at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline in postural sway at 15 weeks
timeFrame: baseline, 15 weeks
measure: Change from baseline on the Falls-Efficacy scale at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline on the Falls Efficacy scale at 15 weeks
timeFrame: baseline, 15 weeks
measure: Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks
timeFrame: baseline, 15 weeks
measure: Change from baseline on the MS Walking Scale-12 at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline on the MS Walking scale-12 at 15 weeks
timeFrame: baseline, 15 weeks
measure: The number of falls and accidental falls
timeFrame: from baseline to 15 weeks
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Neurorehab Mälarsjukhuset
city: Gävle
country: Sweden
facility: Physiotherapy department Gävle hospital
city: Karlskoga
country: Sweden
facility: Rehab unit Karlskoga hospital
city: Linköping
country: Sweden
facility: Primary Health Care
city: Nyköping
country: Sweden
facility: Nyköping hospital
city: Västerås
country: Sweden
facility: Rehab unit Västerås hospital
city: Örebro
country: Sweden
facility: Physiotherapy department University hospital
Study officials:
affiliation: Centre for Health Care Sciences, Örebro County Council
name: Anna Carling, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Medicine Research Centre, Örebro County Council
name: Anette Forsberg, PhD
role: STUDY_CHAIR
affiliation: Centre for Health Care Sciences, Örebro County Council
name: Ylva Nilsagård, PhD
role: STUDY_DIRECTOR
References:
citation: Nilsagard YE, von Koch LK, Nilsson M, Forsberg AS. Balance exercise program reduced falls in people with multiple sclerosis: a single-group, pretest-posttest trial. Arch Phys Med Rehabil. 2014 Dec;95(12):2428-34. doi: 10.1016/j.apmr.2014.06.016. Epub 2014 Jul 6.