Balance and Falls in Multiple Sclerosis

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Group balance training

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Eskilstuna, Sweden
    • Neurorehab Mälarsjukhuset
  • Gävle, Sweden
    • Physiotherapy department Gävle hospital
  • Karlskoga, Sweden
    • Rehab unit Karlskoga hospital
  • Linköping, Sweden
    • Primary Health Care
  • Nyköping, Sweden
    • Nyköping Hospital
  • Västerås, Sweden
    • Rehab unit Västerås hospital
  • Örebro, Sweden
    • Physiotherapy department University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group balance training late start; Participants randomized to late start act as No intervention group during the study period.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Örebro County Council
• Investigators: Study Chair: Anette Forsberg, PhD, Family Medicine Research Centre, Örebro County Council; Principal Investigator: Anna Carling, MSc, Centre for Health Care Sciences, Örebro County Council; Study Director: Ylva Nilsagård, PhD, Centre for Health Care Sciences, Örebro County Council

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: falls; walking; postural balance
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Researchweb 153691