Group Balance Training for People With Multiple Sclerosis
1 other identifier
interventional
87
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Aug 2012
Shorter than P25 for not_applicable multiple-sclerosis
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMarch 27, 2015
March 1, 2015
11 months
April 16, 2012
March 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Bergs balance scale
Functional balance scale in sitting, standing and walking.
Change from Baseline in Bergs balance scale at 7 weeks
Secondary Outcomes (15)
Change from Baseline in Four Square step test
Change from Baseline in Four Square step test at 7 weeks
Change from baseline in Timed chair stands test
Change from baseline in Times Chair stands test at 7 weeks
Change from baseline in Timed Up and Go test
Change from baseline in Timed Up and Go test at 7 weeks
Change from baseline in Functional Gait Assessment
Change from baseline in Functional Gait Assessment at 7 weeks
Change from baseline in Postural sway
Change from baseline in Postural sway at 7 weeks
- +10 more secondary outcomes
Study Arms (2)
Group balance training early start
EXPERIMENTALGroup balance training late start
EXPERIMENTALInterventions
Balance training i group with focus on core stability exercises and dual attention activities.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Örebro County Councillead
- Uppsala-Örebro Regional Research Councilcollaborator
- Norrbacka-Eugenia Foundationcollaborator
Study Sites (7)
Mälarsjukhuset
Eskilstuna, 63188, Sweden
Karlstad hospital
Karlstad, Sweden
Rörelse och hälsa neuro
Linköping, Sweden
Primärvård Mjölby
Mjölby, Sweden
Nyköpings hospital
Nyköping, Sweden
University Hospital Örebro
Örebro, 70185, Sweden
Västerås hospital
Västerås, 72189, Sweden
Related Publications (1)
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.
PMID: 25004466DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anette Forsberg, PhD
Family Medicine Research Centre, Örebro county council
- PRINCIPAL INVESTIGATOR
Ylva Nilsagård, PhD
Centre for Health Care Sciences, Örebro county council
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher, RPT
Study Record Dates
First Submitted
April 16, 2012
First Posted
April 20, 2012
Study Start
August 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
March 27, 2015
Record last verified: 2015-03