NCT02209467

Brief Summary

The study hypothesis is that for people with moderate to severe multiple sclerosis postural balance and walking improve and the risk of accidental falls are reduced after participating in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain a further 7 weeks post training. Multiple Sclerosis (MS) is disease affecting the central nervous system. Walking and postural balance are often affected early in the course of the disease. The risk of falls is large. Many persons with MS have decreased trunk stability compared to healthy persons . In an earlier study including people with mild to moderate MS we found that a period of core stability exercises reduced the risk of falls. In this study the training concept will be applied for persons with more severe walking limitations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 2014

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

Study Start

First participant enrolled

August 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

August 4, 2014

Last Update Submit

October 28, 2015

Conditions

Multiple Sclerosis

Keywords

walkingpostural balancefalls

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Berg Balance Scale at 8 weeks

    baseline, 8 weeks

Secondary Outcomes (20)

  • Change from baseline in 10 repetitions Sit to stand test at 15 weeks

    baseline, 15 weeks

  • Change from baseline in Trunk Impairment scale at 8 weeks

    baseline, 8 weeks

  • Change from baseline in the Trunk Impairment Scale at 15 weeks

    baseline, 15 weeks

  • Change from baseline in the 10 repetition Si to stand test at 8 weeks

    baseline, 8 weeks

  • Change from baseline in the Berg Balance scale at 15 weeks

    baseline, 15 weeks

  • +15 more secondary outcomes

Study Arms (2)

Group balance training late start

NO INTERVENTION

Participants randomized to late start act as No intervention group during the study period.

Group balance training early start

EXPERIMENTAL

Group balance training focusing on core stability exercises 2 times per week for 7 weeks and 2 home training sessions per weeks.

Other: Group balance training

Interventions

Group balance trainingOTHER

Group balance training 60 minutes 2 times per week plus 3-5 home exercises 2 times/week. Exercises focus om core stability in sitting, standing and lying.

Group balance training early start

Eligibility Criteria

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

You may qualify if:

  • diagnosed multiple sclerosis
  • Expanded Disability Scale Score of 5-6.5
  • walking speed of less than 0.8 m/s as tested on a 10 meter walking test

You may not qualify if:

  • Ongoing relapse
  • Cognitive or language difficulties that prohibit participating in the intervention or performing the outcome measures
  • Change in specific MS medication during the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Neurorehab Mälarsjukhuset

Eskilstuna, Sweden

Location

Physiotherapy department Gävle hospital

Gävle, Sweden

Location

Rehab unit Karlskoga hospital

Karlskoga, Sweden

Location

Primary Health Care

Linköping, Sweden

Location

Nyköping hospital

Nyköping, Sweden

Location

Physiotherapy department University hospital

Örebro, Sweden

Location

Rehab unit Västerås hospital

Västerås, 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.

    PMID: 25004466BACKGROUND

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

  • Anna Carling, MSc

    Centre for Health Care Sciences, Örebro County Council

    PRINCIPAL INVESTIGATOR

  • Anette Forsberg, PhD

    Family Medicine Research Centre, Örebro County Council

    STUDY CHAIR

  • Ylva Nilsagård, PhD

    Centre for Health Care Sciences, Örebro County Council

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 6, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

August 1, 2015

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

SE(7)