Group Balance Training for People With Multiple Sclerosis - Full Text View

Purpose

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.

Condition	Intervention
Multiple Sclerosis	Other: Group balance training

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Group Balance Training for People With Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Exercise and Physical Fitness Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Örebro County Council:

Primary Outcome Measures:

Change from Baseline in Bergs balance scale [ Time Frame: Change from Baseline in Bergs balance scale at 7 weeks ] [ Designated as safety issue: No ]
Functional balance scale in sitting, standing and walking.

Secondary Outcome Measures:

Change from Baseline in Four Square step test [ Time Frame: Change from Baseline in Four Square step test at 7 weeks ] [ Designated as safety issue: No ]
Dynamic balance
Change from baseline in Timed chair stands test [ Time Frame: Change from baseline in Times Chair stands test at 7 weeks ] [ Designated as safety issue: No ]
Functional leg strength, rising 10 times from a chair.
Change from baseline in Timed Up and Go test [ Time Frame: Change from baseline in Timed Up and Go test at 7 weeks ] [ Designated as safety issue: No ]
Functional mobility.
Change from baseline in Functional Gait Assessment [ Time Frame: Change from baseline in Functional Gait Assessment at 7 weeks ] [ Designated as safety issue: No ]
Gait-related activities
Change from baseline in Postural sway [ Time Frame: Change from baseline in Postural sway at 7 weeks ] [ Designated as safety issue: No ]
Using a sway meter postural sway in standing still is assessed.
Change from baseline in Activities-specific Balance scale [ Time Frame: Change from baseline in Activities-specific Balance scale at 7 weeks ] [ Designated as safety issue: No ]
16 item questionnaire that includes items on balance self-efficacy
Change from baseline in 12-item Multiple Sclerosis Walking scale [ Time Frame: Change from baseline in 12-item Multiple Sclerosis Walking scale at 7 weeks ] [ Designated as safety issue: No ]
self-reported limitations in walking.
Change from Baseline in Bergs balance scale [ Time Frame: Change from Baseline in Bergs balance scale at 14 weeks ] [ Designated as safety issue: No ]
Functional balance in sitting, standing and walking
Change from Baseline in Four Square step test [ Time Frame: Change from baseline in Four Square step test at 14 weeks ] [ Designated as safety issue: No ]
Dynamic balance
Change from baseline in Times Chair stands test [ Time Frame: Change from baseline in Times Chair stands test at 14 weeks ] [ Designated as safety issue: No ]
Functional lower extremity strength
Change from baseline in Timed Up and Go test [ Time Frame: Change from baseline in Timed Up and Go test at 14 weeks ] [ Designated as safety issue: No ]
Functional mobility
Change from baseline in Functional Gait Assessment [ Time Frame: Change from baseline in Functional Gait Assessment at 14 weeks ] [ Designated as safety issue: No ]
Gait-related activities
Change from baseline in postoral sway [ Time Frame: Change from baseline in postoral sway at 14 weeks ] [ Designated as safety issue: No ]
Using a sway meter postural sway in standing still is assessed.
Change from baseline in Activities-specific Balance scale [ Time Frame: Change from baseline in Activities-specific Balance scale at 14 weeks ] [ Designated as safety issue: No ]
Balance self-efficacy
Change from baseline in 12-item Multiple Sclerosis Walking scale [ Time Frame: Change from baseline in 12-item Multiple Sclerosis Walking scale at 14 weeks ] [ Designated as safety issue: No ]
self-reported limitations in walking

Estimated Enrollment:	70
Study Start Date:	August 2012
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group balance training early start	Other: Group balance training Balance training i group with focus on core stability exercises and dual attention activities.
Experimental: Group balance training late start	Other: Group balance training Balance training i group with focus on core stability exercises and dual attention activities.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582126

Contacts

Contact: Anette Forsberg, PhD	+46-19-602 5788	anette.forsberg@orebroll.se
Contact: Ylva Nilsagård, PhD	+46-19-6026223	ylva.nilsagard@orebroll.se

Locations

Sweden
Mälarsjukhuset	Not yet recruiting
Eskilstuna, Sweden, 63188
Principal Investigator: Ylva Nilsagård, PhD
Karlstad hospital	Not yet recruiting
Karlstad, Sweden
Principal Investigator: Lena Sanner, RPT
Nyköpings hospital	Not yet recruiting
Nyköping, Sweden
Principal Investigator: Oskar Davidsson, RPT
Uppsala University hospital	Not yet recruiting
Uppsala, Sweden
Principal Investigator: Lena von Koch, PhD
Västerås hospital	Not yet recruiting
Västerås, Sweden, 72189
Principal Investigator: Ingrid Lundström, RPT
University Hospital Örebro	Not yet recruiting
Örebro, Sweden, 70185
Principal Investigator: Anette Forsberg, PhD

Sponsors and Collaborators

Örebro County Council

Regional Research council in the Örebro-Uppsala region

Investigators

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

More Information

No publications provided

Responsible Party:	Anette Forsberg, PhD, Researcher, RPT, Örebro County Council
ClinicalTrials.gov Identifier:	NCT01582126 History of Changes
Other Study ID Numbers:	Ö-1-12
Study First Received:	April 16, 2012
Last Updated:	April 30, 2012
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Örebro County Council:

multiple sclerosis
physical therapy
postural control

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013