Group Balance Training for People With Multiple Sclerosis

March 26, 2015 updated by: Anette Forsberg, PhD, Örebro County Council
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Bergs balance scale
Time Frame: Change from Baseline in Bergs balance scale at 7 weeks
Functional balance scale in sitting, standing and walking.
Change from Baseline in Bergs balance scale at 7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Four Square step test
Time Frame: Change from Baseline in Four Square step test at 7 weeks
Dynamic balance
Change from Baseline in Four Square step test at 7 weeks
Change from baseline in Timed chair stands test
Time Frame: Change from baseline in Times Chair stands test at 7 weeks
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
Time Frame: Change from baseline in Timed Up and Go test at 7 weeks
Functional mobility.
Change from baseline in Timed Up and Go test at 7 weeks
Change from baseline in Functional Gait Assessment
Time Frame: Change from baseline in Functional Gait Assessment at 7 weeks
Gait-related activities
Change from baseline in Functional Gait Assessment at 7 weeks
Change from baseline in Postural sway
Time Frame: Change from baseline in Postural sway at 7 weeks
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
Time Frame: Change from baseline in Activities-specific Balance scale at 7 weeks
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
Time Frame: Change from baseline in 12-item Multiple Sclerosis Walking scale at 7 weeks
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
Time Frame: Change from Baseline in Bergs balance scale at 14 weeks
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
Time Frame: Change from baseline in Four Square step test at 14 weeks
Dynamic balance
Change from baseline in Four Square step test at 14 weeks
Change from baseline in Times Chair stands test
Time Frame: Change from baseline in Times Chair stands test at 14 weeks
Functional lower extremity strength
Change from baseline in Times Chair stands test at 14 weeks
Change from baseline in Timed Up and Go test
Time Frame: Change from baseline in Timed Up and Go test at 14 weeks
Functional mobility
Change from baseline in Timed Up and Go test at 14 weeks
Change from baseline in Functional Gait Assessment
Time Frame: Change from baseline in Functional Gait Assessment at 14 weeks
Gait-related activities
Change from baseline in Functional Gait Assessment at 14 weeks
Change from baseline in postoral sway
Time Frame: Change from baseline in postoral sway at 14 weeks
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
Time Frame: Change from baseline in Activities-specific Balance scale at 14 weeks
Balance self-efficacy
Change from baseline in Activities-specific Balance scale at 14 weeks
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
self-reported limitations in walking
Change from baseline in 12-item Multiple Sclerosis Walking scale at 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Örebro County Council

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norrbacka-Eugenia Foundation
Uppsala-Örebro Regional Research Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ö-1-12

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