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Group Balance Training for People With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Group balance training
Sponsored by
Örebro County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, physical therapy, postural control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mälarsjukhuset
  • Karlstad hospital
  • Rörelse och hälsa neuro
  • Primärvård Mjölby
  • Nyköpings hospital
  • Västerås hospital
  • University Hospital Örebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group balance training early start

Group balance training late start

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in Bergs balance scale
Functional balance scale in sitting, standing and walking.

Secondary Outcome Measures

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

Full Information

First Posted
April 16, 2012
Last Updated
March 26, 2015
Sponsor
Örebro County Council
Collaborators
Uppsala-Örebro Regional Research Council, Norrbacka-Eugenia Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01582126
Brief Title
Group Balance Training for People With Multiple Sclerosis
Official Title
Group Balance Training for People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
Collaborators
Uppsala-Örebro Regional Research Council, Norrbacka-Eugenia Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, physical therapy, postural control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group balance training early start
Arm Type
Experimental
Arm Title
Group balance training late start
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Group balance training
Intervention Description
Balance training i group with focus on core stability exercises and dual attention activities.
Primary Outcome Measure Information:
Title
Change from Baseline in Bergs balance scale
Description
Functional balance scale in sitting, standing and walking.
Time Frame
Change from Baseline in Bergs balance scale at 7 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Four Square step test
Description
Dynamic balance
Time Frame
Change from Baseline in Four Square step test at 7 weeks
Title
Change from baseline in Timed chair stands test
Description
Functional leg strength, rising 10 times from a chair.
Time Frame
Change from baseline in Times Chair stands test at 7 weeks
Title
Change from baseline in Timed Up and Go test
Description
Functional mobility.
Time Frame
Change from baseline in Timed Up and Go test at 7 weeks
Title
Change from baseline in Functional Gait Assessment
Description
Gait-related activities
Time Frame
Change from baseline in Functional Gait Assessment at 7 weeks
Title
Change from baseline in Postural sway
Description
Using a sway meter postural sway in standing still is assessed.
Time Frame
Change from baseline in Postural sway at 7 weeks
Title
Change from baseline in Activities-specific Balance scale
Description
16 item questionnaire that includes items on balance self-efficacy
Time Frame
Change from baseline in Activities-specific Balance scale at 7 weeks
Title
Change from baseline in 12-item Multiple Sclerosis Walking scale
Description
self-reported limitations in walking.
Time Frame
Change from baseline in 12-item Multiple Sclerosis Walking scale at 7 weeks
Title
Change from Baseline in Bergs balance scale
Description
Functional balance in sitting, standing and walking
Time Frame
Change from Baseline in Bergs balance scale at 14 weeks
Title
Change from Baseline in Four Square step test
Description
Dynamic balance
Time Frame
Change from baseline in Four Square step test at 14 weeks
Title
Change from baseline in Times Chair stands test
Description
Functional lower extremity strength
Time Frame
Change from baseline in Times Chair stands test at 14 weeks
Title
Change from baseline in Timed Up and Go test
Description
Functional mobility
Time Frame
Change from baseline in Timed Up and Go test at 14 weeks
Title
Change from baseline in Functional Gait Assessment
Description
Gait-related activities
Time Frame
Change from baseline in Functional Gait Assessment at 14 weeks
Title
Change from baseline in postoral sway
Description
Using a sway meter postural sway in standing still is assessed.
Time Frame
Change from baseline in postoral sway at 14 weeks
Title
Change from baseline in Activities-specific Balance scale
Description
Balance self-efficacy
Time Frame
Change from baseline in Activities-specific Balance scale at 14 weeks
Title
Change from baseline in 12-item Multiple Sclerosis Walking scale
Description
self-reported limitations in walking
Time Frame
Change from baseline in 12-item Multiple Sclerosis Walking scale at 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anette Forsberg, PhD
Organizational Affiliation
Family Medicine Research Centre, Örebro county council
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ylva Nilsagård, PhD
Organizational Affiliation
Centre for Health Care Sciences, Örebro county council
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mälarsjukhuset
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
Facility Name
Karlstad hospital
City
Karlstad
Country
Sweden
Facility Name
Rörelse och hälsa neuro
City
Linköping
Country
Sweden
Facility Name
Primärvård Mjölby
City
Mjölby
Country
Sweden
Facility Name
Nyköpings hospital
City
Nyköping
Country
Sweden
Facility Name
Västerås hospital
City
Västerås
ZIP/Postal Code
72189
Country
Sweden
Facility Name
University Hospital Örebro
City
Örebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25004466
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.
Results Reference
derived

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Group Balance Training for People With Multiple Sclerosis

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