Balance and Falls in Multiple Sclerosis

NCT ID: NCT02209467

Last Updated: 2015-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group balance training late start

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group balance training early start

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

Group Type EXPERIMENTAL

Group balance training

Intervention Type OTHER

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.

Interventions

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Group balance training

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro County Council

OTHER_GOV

Sponsor Role lead

Responsible Party

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Anette Forsberg, PhD

PhD, lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Carling, MSc

Role: PRINCIPAL_INVESTIGATOR

Centre for Health Care Sciences, Örebro County Council

Anette Forsberg, PhD

Role: STUDY_CHAIR

Family Medicine Research Centre, Örebro County Council

Ylva Nilsagård, PhD

Role: STUDY_DIRECTOR

Centre for Health Care Sciences, Örebro County Council

Locations

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Neurorehab Mälarsjukhuset

Eskilstuna, , Sweden

Site Status

Physiotherapy department Gävle hospital

Gävle, , Sweden

Site Status

Rehab unit Karlskoga hospital

Karlskoga, , Sweden

Site Status

Primary Health Care

Linköping, , Sweden

Site Status

Nyköping hospital

Nyköping, , Sweden

Site Status

Physiotherapy department University hospital

Örebro, , Sweden

Site Status

Rehab unit Västerås hospital

Västerås, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 25004466 (View on PubMed)

Other Identifiers

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Researchweb 153691

Identifier Type: -

Identifier Source: org_study_id

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