Group Balance Training for People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Group Balance Training for People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582126
• Other study ID #: Ö-1-12
• Status: Completed
• Phase: N/A
• First received: April 16, 2012
• Last updated: March 26, 2015
• Start date: August 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2015
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Group balance training
Balance training i group with focus on core stability exercises and dual attention activities.

Locations

Country	Name	City	State
Sweden	Mälarsjukhuset	Eskilstuna
Sweden	Karlstad hospital	Karlstad
Sweden	Rörelse och hälsa neuro	Linköping
Sweden	Primärvård Mjölby	Mjölby
Sweden	Nyköpings hospital	Nyköping
Sweden	University Hospital Örebro	Örebro
Sweden	Västerås hospital	Västerås

Sponsors (3)

Lead Sponsor	Collaborator
Örebro County Council	Norrbacka-Eugenia Foundation, Uppsala-Örebro Regional Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from Baseline in Four Square step test	Dynamic balance	Change from Baseline in Four Square step test at 7 weeks	No
Secondary	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	No
Secondary	Change from baseline in Timed Up and Go test	Functional mobility.	Change from baseline in Timed Up and Go test at 7 weeks	No
Secondary	Change from baseline in Functional Gait Assessment	Gait-related activities	Change from baseline in Functional Gait Assessment at 7 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change from Baseline in Bergs balance scale	Functional balance in sitting, standing and walking	Change from Baseline in Bergs balance scale at 14 weeks	No
Secondary	Change from Baseline in Four Square step test	Dynamic balance	Change from baseline in Four Square step test at 14 weeks	No
Secondary	Change from baseline in Times Chair stands test	Functional lower extremity strength	Change from baseline in Times Chair stands test at 14 weeks	No
Secondary	Change from baseline in Timed Up and Go test	Functional mobility	Change from baseline in Timed Up and Go test at 14 weeks	No
Secondary	Change from baseline in Functional Gait Assessment	Gait-related activities	Change from baseline in Functional Gait Assessment at 14 weeks	No
Secondary	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	No
Secondary	Change from baseline in Activities-specific Balance scale	Balance self-efficacy	Change from baseline in Activities-specific Balance scale at 14 weeks	No
Secondary	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	No