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Balance and Falls in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02209467
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Anette Forsberg, PhD, Örebro County Council

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Group balance training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins
Study Start Date : August 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from baseline in Berg Balance Scale at 8 weeks [ Time Frame: baseline, 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in 10 repetitions Sit to stand test at 15 weeks [ Time Frame: baseline, 15 weeks ]
  2. Change from baseline in Trunk Impairment scale at 8 weeks [ Time Frame: baseline, 8 weeks ]
  3. Change from baseline in the Trunk Impairment Scale at 15 weeks [ Time Frame: baseline, 15 weeks ]
  4. Change from baseline in the 10 repetition Si to stand test at 8 weeks [ Time Frame: baseline, 8 weeks ]
  5. Change from baseline in the Berg Balance scale at 15 weeks [ Time Frame: baseline, 15 weeks ]
  6. Change from baseline on the Timed Up and Go test at 8 weeks [ Time Frame: baseline, 8 weeks ]
  7. Change from baseline on the Timed Up and Go test at 15 weeks [ Time Frame: baseline, 15 weeks ]
  8. Change from baseline on the10 meter walking test at 8 weeks [ Time Frame: baseline, 8 weeks ]
  9. Change from baseline on the 10 meter walking test at 15 weks [ Time Frame: baseline, 15 weeks ]
  10. Change from baseline on the 2 minutes walking test at 8 weeks [ Time Frame: baseline, 8 weeks ]
  11. Change from baseline on the 2 minutes walking test at 15 weeks [ Time Frame: baseline, 15 weeks ]
  12. Change from baseline in postural sway at 8 weeks [ Time Frame: baseline, 8 weeks ]
  13. Change from baseline in postural sway at 15 weeks [ Time Frame: baseline, 15 weeks ]
    postural sway in standing on the floor is assessed

  14. Change from baseline on the Falls-Efficacy scale at 8 weeks [ Time Frame: baseline, 8 weeks ]
  15. Change from baseline on the Falls Efficacy scale at 15 weeks [ Time Frame: baseline, 15 weeks ]
  16. Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks [ Time Frame: baseline, 8 weeks ]
  17. Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks [ Time Frame: baseline, 15 weeks ]
  18. Change from baseline on the MS Walking Scale-12 at 8 weeks [ Time Frame: baseline, 8 weeks ]
  19. Change from baseline on the MS Walking scale-12 at 15 weeks [ Time Frame: baseline, 15 weeks ]
  20. The number of falls and accidental falls [ Time Frame: from baseline to 15 weeks ]
    the number of falls and accidental falls are noted by the participant in a study-specific falls diary.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209467


Locations
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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
Rehab unit Västerås hospital
Västerås, Sweden
Physiotherapy department University hospital
Örebro, Sweden
Sponsors and Collaborators
Örebro County Council
Investigators
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Principal Investigator: Anna Carling, MSc Centre for Health Care Sciences, Örebro County Council
Study Chair: Anette Forsberg, PhD Family Medicine Research Centre, Örebro County Council
Study Director: Ylva Nilsagård, PhD Centre for Health Care Sciences, Örebro County Council

Publications:
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Responsible Party: Anette Forsberg, PhD, PhD, lecturer, Örebro County Council
ClinicalTrials.gov Identifier: NCT02209467    
Other Study ID Numbers: Researchweb 153691
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Keywords provided by Anette Forsberg, PhD, Örebro County Council:
walking
postural balance
falls
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases