NCT01582126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

April 16, 2012

Last Update Submit

March 26, 2015

Conditions

Keywords

multiple sclerosisphysical therapypostural control

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Change from Baseline in Four Square step test

    Change from Baseline in Four Square step test at 7 weeks

  • Change from baseline in Timed chair stands test

    Change from baseline in Times Chair stands test at 7 weeks

  • Change from baseline in Timed Up and Go test

    Change from baseline in Timed Up and Go test at 7 weeks

  • Change from baseline in Functional Gait Assessment

    Change from baseline in Functional Gait Assessment at 7 weeks

  • Change from baseline in Postural sway

    Change from baseline in Postural sway at 7 weeks

  • +10 more secondary outcomes

Study Arms (2)

Group balance training early start

EXPERIMENTAL
Other: Group balance training

Group balance training late start

EXPERIMENTAL
Other: Group balance training

Interventions

Balance training i group with focus on core stability exercises and dual attention activities.

Group balance training early startGroup balance training late start

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mälarsjukhuset

Eskilstuna, 63188, Sweden

Location

Karlstad hospital

Karlstad, Sweden

Location

Rörelse och hälsa neuro

Linköping, Sweden

Location

Primärvård Mjölby

Mjölby, Sweden

Location

Nyköpings hospital

Nyköping, Sweden

Location

University Hospital Örebro

Örebro, 70185, Sweden

Location

Västerås hospital

Västerås, 72189, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anette Forsberg, PhD

    Family Medicine Research Centre, Örebro county council

    STUDY CHAIR
  • Ylva Nilsagård, PhD

    Centre for Health Care Sciences, Örebro county council

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, RPT

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 20, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations