Balance and Falls in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209467
• Other study ID #: Researchweb 153691
• Status: Completed
• Phase: N/A
• First received: August 4, 2014
• Last updated: October 28, 2015
• Start date: August 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Ethical Review boardSweden: Swedish Research CouncilSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Sweden	Neurorehab Mälarsjukhuset	Eskilstuna
Sweden	Physiotherapy department Gävle hospital	Gävle
Sweden	Rehab unit Karlskoga hospital	Karlskoga
Sweden	Primary Health Care	Linköping
Sweden	Nyköping hospital	Nyköping
Sweden	Physiotherapy department University hospital	Örebro
Sweden	Rehab unit Västerås hospital	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Örebro County Council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Nilsagård 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Berg Balance Scale at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in 10 repetitions Sit to stand test at 15 weeks		baseline, 15 weeks	No
Secondary	Change from baseline in Trunk Impairment scale at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in the Trunk Impairment Scale at 15 weeks		baseline, 15 weeks	No
Secondary	Change from baseline in the 10 repetition Si to stand test at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in the Berg Balance scale at 15 weeks		baseline, 15 weeks	No
Secondary	Change from baseline on the Timed Up and Go test at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline on the Timed Up and Go test at 15 weeks		baseline, 15 weeks	No
Secondary	Change from baseline on the10 meter walking test at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline on the 10 meter walking test at 15 weks		baseline, 15 weeks	No
Secondary	Change from baseline on the 2 minutes walking test at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline on the 2 minutes walking test at 15 weeks		baseline, 15 weeks	No
Secondary	Change from baseline in postural sway at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in postural sway at 15 weeks	postural sway in standing on the floor is assessed	baseline, 15 weeks	No
Secondary	Change from baseline on the Falls-Efficacy scale at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline on the Falls Efficacy scale at 15 weeks		baseline, 15 weeks	No
Secondary	Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks		baseline, 15 weeks	No
Secondary	Change from baseline on the MS Walking Scale-12 at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline on the MS Walking scale-12 at 15 weeks		baseline, 15 weeks	No
Secondary	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	Yes