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Balance and Falls in 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 walking, postural balance, falls

Eligibility Criteria

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

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

Sites / Locations

  • Neurorehab Mälarsjukhuset
  • Physiotherapy department Gävle hospital
  • Rehab unit Karlskoga hospital
  • Primary Health Care
  • Nyköping hospital
  • Rehab unit Västerås hospital
  • Physiotherapy department University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group balance training late start

Group balance training early start

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Berg Balance Scale at 8 weeks

Secondary Outcome Measures

Change from baseline in 10 repetitions Sit to stand test at 15 weeks
Change from baseline in Trunk Impairment scale at 8 weeks
Change from baseline in the Trunk Impairment Scale at 15 weeks
Change from baseline in the 10 repetition Si to stand test at 8 weeks
Change from baseline in the Berg Balance scale at 15 weeks
Change from baseline on the Timed Up and Go test at 8 weeks
Change from baseline on the Timed Up and Go test at 15 weeks
Change from baseline on the10 meter walking test at 8 weeks
Change from baseline on the 10 meter walking test at 15 weks
Change from baseline on the 2 minutes walking test at 8 weeks
Change from baseline on the 2 minutes walking test at 15 weeks
Change from baseline in postural sway at 8 weeks
Change from baseline in postural sway at 15 weeks
postural sway in standing on the floor is assessed
Change from baseline on the Falls-Efficacy scale at 8 weeks
Change from baseline on the Falls Efficacy scale at 15 weeks
Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks
Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks
Change from baseline on the MS Walking Scale-12 at 8 weeks
Change from baseline on the MS Walking scale-12 at 15 weeks
The number of falls and accidental falls
the number of falls and accidental falls are noted by the participant in a study-specific falls diary.

Full Information

First Posted
August 4, 2014
Last Updated
October 28, 2015
Sponsor
Örebro County Council
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1. Study Identification

Unique Protocol Identification Number
NCT02209467
Brief Title
Balance and Falls in Multiple Sclerosis
Official Title
Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
walking, postural balance, falls

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group balance training late start
Arm Type
No Intervention
Arm Description
Participants randomized to late start act as No intervention group during the study period.
Arm Title
Group balance training early start
Arm Type
Experimental
Arm Description
Group balance training focusing on core stability exercises 2 times per week for 7 weeks and 2 home training sessions per weeks.
Intervention Type
Other
Intervention Name(s)
Group balance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Berg Balance Scale at 8 weeks
Time Frame
baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in 10 repetitions Sit to stand test at 15 weeks
Time Frame
baseline, 15 weeks
Title
Change from baseline in Trunk Impairment scale at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in the Trunk Impairment Scale at 15 weeks
Time Frame
baseline, 15 weeks
Title
Change from baseline in the 10 repetition Si to stand test at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in the Berg Balance scale at 15 weeks
Time Frame
baseline, 15 weeks
Title
Change from baseline on the Timed Up and Go test at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline on the Timed Up and Go test at 15 weeks
Time Frame
baseline, 15 weeks
Title
Change from baseline on the10 meter walking test at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline on the 10 meter walking test at 15 weks
Time Frame
baseline, 15 weeks
Title
Change from baseline on the 2 minutes walking test at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline on the 2 minutes walking test at 15 weeks
Time Frame
baseline, 15 weeks
Title
Change from baseline in postural sway at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in postural sway at 15 weeks
Description
postural sway in standing on the floor is assessed
Time Frame
baseline, 15 weeks
Title
Change from baseline on the Falls-Efficacy scale at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline on the Falls Efficacy scale at 15 weeks
Time Frame
baseline, 15 weeks
Title
Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks
Time Frame
baseline, 15 weeks
Title
Change from baseline on the MS Walking Scale-12 at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline on the MS Walking scale-12 at 15 weeks
Time Frame
baseline, 15 weeks
Title
The number of falls and accidental falls
Description
the number of falls and accidental falls are noted by the participant in a study-specific falls diary.
Time Frame
from baseline to 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Carling, MSc
Organizational Affiliation
Centre for Health Care Sciences, Örebro County Council
Official's Role
Principal Investigator
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
Study Director
Facility Information:
Facility Name
Neurorehab Mälarsjukhuset
City
Eskilstuna
Country
Sweden
Facility Name
Physiotherapy department Gävle hospital
City
Gävle
Country
Sweden
Facility Name
Rehab unit Karlskoga hospital
City
Karlskoga
Country
Sweden
Facility Name
Primary Health Care
City
Linköping
Country
Sweden
Facility Name
Nyköping hospital
City
Nyköping
Country
Sweden
Facility Name
Rehab unit Västerås hospital
City
Västerås
Country
Sweden
Facility Name
Physiotherapy department University hospital
City
Örebro
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.
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Balance and Falls in Multiple Sclerosis

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