Group Balance Training for People With Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Group balance training

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Eskilstuna, Sweden, 63188
    • Mälarsjukhuset
  • Karlstad, Sweden
    • Karlstad hospital
  • Linköping, Sweden
    • Rörelse och hälsa neuro
  • Mjölby, Sweden
    • Primärvård Mjölby
  • Nyköping, Sweden
    • Nyköpings hospital
  • Västerås, Sweden, 72189
    • Västerås Hospital
  • Örebro, Sweden, 70185
    • University Hospital Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Four Square step test	Dynamic balance	Change from Baseline in Four Square step test at 7 weeks
Change from baseline in Timed chair stands test	Functional leg strength, rising 10 times from a chair.	Change from baseline in Times Chair stands test at 7 weeks
Change from baseline in Timed Up and Go test	Functional mobility.	Change from baseline in Timed Up and Go test at 7 weeks
Change from baseline in Functional Gait Assessment	Gait-related activities	Change from baseline in Functional Gait Assessment at 7 weeks
Change from baseline in Postural sway	Using a sway meter postural sway in standing still is assessed.	Change from baseline in Postural sway at 7 weeks
Change from baseline in Activities-specific Balance scale	16 item questionnaire that includes items on balance self-efficacy	Change from baseline in Activities-specific Balance scale at 7 weeks
Change from baseline in 12-item Multiple Sclerosis Walking scale	self-reported limitations in walking.	Change from baseline in 12-item Multiple Sclerosis Walking scale at 7 weeks
Change from Baseline in Bergs balance scale	Functional balance in sitting, standing and walking	Change from Baseline in Bergs balance scale at 14 weeks
Change from Baseline in Four Square step test	Dynamic balance	Change from baseline in Four Square step test at 14 weeks
Change from baseline in Times Chair stands test	Functional lower extremity strength	Change from baseline in Times Chair stands test at 14 weeks
Change from baseline in Timed Up and Go test	Functional mobility	Change from baseline in Timed Up and Go test at 14 weeks
Change from baseline in Functional Gait Assessment	Gait-related activities	Change from baseline in Functional Gait Assessment at 14 weeks
Change from baseline in postoral sway	Using a sway meter postural sway in standing still is assessed.	Change from baseline in postoral sway at 14 weeks
Change from baseline in Activities-specific Balance scale	Balance self-efficacy	Change from baseline in Activities-specific Balance scale at 14 weeks
Change from baseline in 12-item Multiple Sclerosis Walking scale	self-reported limitations in walking	Change from baseline in 12-item Multiple Sclerosis Walking scale at 14 weeks

Collaborators and Investigators

• Sponsor: Örebro County Council
• Collaborators: Norrbacka-Eugenia Foundation; Uppsala-Örebro Regional Research Council
• 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 16, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: multiple sclerosis; physical therapy; postural control
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Ö-1-12