Balance and Falls in Multiple Sclerosis

Study Overview
=================
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.

Official Title
-----------------
Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Group balance training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group balance training late start<br>Participants randomized to late start act as No intervention group during the study period. | |
| Experimental: Group balance training early start<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Berg Balance Scale at 8 weeks |  | baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from baseline on the Timed Up and Go test at 8 weeks |  | baseline, 8 weeks | 
| Change from baseline on the Timed Up and Go test at 15 weeks |  | baseline, 15 weeks | 
| Change from baseline on the10 meter walking test at 8 weeks |  | baseline, 8 weeks | 
| Change from baseline on the 10 meter walking test at 15 weks |  | baseline, 15 weeks | 
| Change from baseline on the 2 minutes walking test at 8 weeks |  | baseline, 8 weeks | 
| Change from baseline on the 2 minutes walking test at 15 weeks |  | baseline, 15 weeks | 
| Change from baseline in postural sway at 8 weeks |  | baseline, 8 weeks | 
| Change from baseline in postural sway at 15 weeks | postural sway in standing on the floor is assessed | baseline, 15 weeks | 
| Change from baseline on the Falls-Efficacy scale at 8 weeks |  | baseline, 8 weeks | 
| Change from baseline on the Falls Efficacy scale at 15 weeks |  | baseline, 15 weeks | 
| Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks |  | baseline, 8 weeks | 
| Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks |  | baseline, 15 weeks | 
| Change from baseline on the MS Walking Scale-12 at 8 weeks |  | baseline, 8 weeks | 
| Change from baseline on the MS Walking scale-12 at 15 weeks |  | baseline, 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. | from baseline to 15 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
walking, postural balance, falls