Clinical trial NCT01582126: Group Balance Training for People With Multiple Sclerosis
Official title: Group Balance Training for People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
physical therapy
postural control
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
Collaborators: name: Uppsala-Örebro Regional Research Council
name: Norrbacka-Eugenia Foundation
First posted: 2012-04-20
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Bergs balance scale
timeFrame: Change from Baseline in Bergs balance scale at 7 weeks
Secondary outcomes:
measure: Change from Baseline in Four Square step test
timeFrame: Change from Baseline in Four Square step test at 7 weeks
measure: Change from baseline in Timed chair stands test
timeFrame: Change from baseline in Times Chair stands test at 7 weeks
measure: Change from baseline in Timed Up and Go test
timeFrame: Change from baseline in Timed Up and Go test at 7 weeks
measure: Change from baseline in Functional Gait Assessment
timeFrame: Change from baseline in Functional Gait Assessment at 7 weeks
measure: Change from baseline in Postural sway
timeFrame: Change from baseline in Postural sway at 7 weeks
measure: Change from baseline in Activities-specific Balance scale
timeFrame: Change from baseline in Activities-specific Balance scale at 7 weeks
measure: Change from baseline in 12-item Multiple Sclerosis Walking scale
timeFrame: Change from baseline in 12-item Multiple Sclerosis Walking scale at 7 weeks
measure: Change from Baseline in Bergs balance scale
timeFrame: Change from Baseline in Bergs balance scale at 14 weeks
measure: Change from Baseline in Four Square step test
timeFrame: Change from baseline in Four Square step test at 14 weeks
measure: Change from baseline in Times Chair stands test
timeFrame: Change from baseline in Times Chair stands test at 14 weeks
measure: Change from baseline in Timed Up and Go test
timeFrame: Change from baseline in Timed Up and Go test at 14 weeks
measure: Change from baseline in Functional Gait Assessment
timeFrame: Change from baseline in Functional Gait Assessment at 14 weeks
measure: Change from baseline in postoral sway
timeFrame: Change from baseline in postoral sway at 14 weeks
measure: Change from baseline in Activities-specific Balance scale
timeFrame: Change from baseline in Activities-specific Balance scale at 14 weeks
measure: Change from baseline in 12-item Multiple Sclerosis Walking scale
timeFrame: Change from baseline in 12-item Multiple Sclerosis Walking scale at 14 weeks
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset
city: Karlstad
country: Sweden
facility: Karlstad hospital
city: Linköping
country: Sweden
facility: Rörelse och hälsa neuro
city: Mjölby
country: Sweden
facility: Primärvård Mjölby
city: Nyköping
country: Sweden
facility: Nyköpings hospital
city: Västerås
country: Sweden
facility: Västerås hospital
city: Örebro
country: Sweden
facility: University Hospital Örebro
Study officials:
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: PRINCIPAL_INVESTIGATOR
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.