Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Group Balance Training for People With Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Regional Research council in the Örebro-Uppsala region
Information provided by (Responsible Party):
Anette Forsberg, PhD, Örebro County Council
ClinicalTrials.gov Identifier:
NCT01582126
First received: April 16, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

People with multiple sclerosis (MS) often have affected balance capacity and an increased risk for falls. A risk factor for falls are activities requiring dual attention. Another factor leading to reduced balance capacity is trunk stability, and decreased trunk stability has been seen in people with MS compared to healthy controls. Earlier studies using core stability exercises have shown positive effects on balance, compared to no training. In Sweden, physical therapy for people with MS has often included group training. However, evidence for this intervention is scarce. The aim of this study is therefore to investigate balance training in group. The balance training includes core stability exercises and dual attention activities. A multi-centre study is planned with a waiting-list design. Participants are randomised to either exercise group with early start or with late start. The group balance training includes training 60 minutes 2 times per week for 7 weeks.


Condition Intervention
Multiple Sclerosis
Other: Group balance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Group Balance Training for People With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Örebro County Council:

Primary Outcome Measures:
  • Change from Baseline in Bergs balance scale [ Time Frame: Change from Baseline in Bergs balance scale at 7 weeks ] [ Designated as safety issue: No ]
    Functional balance scale in sitting, standing and walking.


Secondary Outcome Measures:
  • Change from Baseline in Four Square step test [ Time Frame: Change from Baseline in Four Square step test at 7 weeks ] [ Designated as safety issue: No ]
    Dynamic balance

  • Change from baseline in Timed chair stands test [ Time Frame: Change from baseline in Times Chair stands test at 7 weeks ] [ Designated as safety issue: No ]
    Functional leg strength, rising 10 times from a chair.

  • Change from baseline in Timed Up and Go test [ Time Frame: Change from baseline in Timed Up and Go test at 7 weeks ] [ Designated as safety issue: No ]
    Functional mobility.

  • Change from baseline in Functional Gait Assessment [ Time Frame: Change from baseline in Functional Gait Assessment at 7 weeks ] [ Designated as safety issue: No ]
    Gait-related activities

  • Change from baseline in Postural sway [ Time Frame: Change from baseline in Postural sway at 7 weeks ] [ Designated as safety issue: No ]
    Using a sway meter postural sway in standing still is assessed.

  • Change from baseline in Activities-specific Balance scale [ Time Frame: Change from baseline in Activities-specific Balance scale at 7 weeks ] [ Designated as safety issue: No ]
    16 item questionnaire that includes items on balance self-efficacy

  • Change from baseline in 12-item Multiple Sclerosis Walking scale [ Time Frame: Change from baseline in 12-item Multiple Sclerosis Walking scale at 7 weeks ] [ Designated as safety issue: No ]
    self-reported limitations in walking.

  • Change from Baseline in Bergs balance scale [ Time Frame: Change from Baseline in Bergs balance scale at 14 weeks ] [ Designated as safety issue: No ]
    Functional balance in sitting, standing and walking

  • Change from Baseline in Four Square step test [ Time Frame: Change from baseline in Four Square step test at 14 weeks ] [ Designated as safety issue: No ]
    Dynamic balance

  • Change from baseline in Times Chair stands test [ Time Frame: Change from baseline in Times Chair stands test at 14 weeks ] [ Designated as safety issue: No ]
    Functional lower extremity strength

  • Change from baseline in Timed Up and Go test [ Time Frame: Change from baseline in Timed Up and Go test at 14 weeks ] [ Designated as safety issue: No ]
    Functional mobility

  • Change from baseline in Functional Gait Assessment [ Time Frame: Change from baseline in Functional Gait Assessment at 14 weeks ] [ Designated as safety issue: No ]
    Gait-related activities

  • Change from baseline in postoral sway [ Time Frame: Change from baseline in postoral sway at 14 weeks ] [ Designated as safety issue: No ]
    Using a sway meter postural sway in standing still is assessed.

  • Change from baseline in Activities-specific Balance scale [ Time Frame: Change from baseline in Activities-specific Balance scale at 14 weeks ] [ Designated as safety issue: No ]
    Balance self-efficacy

  • Change from baseline in 12-item Multiple Sclerosis Walking scale [ Time Frame: Change from baseline in 12-item Multiple Sclerosis Walking scale at 14 weeks ] [ Designated as safety issue: No ]
    self-reported limitations in walking


Enrollment: 87
Study Start Date: August 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group balance training early start Other: Group balance training
Balance training i group with focus on core stability exercises and dual attention activities.
Experimental: Group balance training late start Other: Group balance training
Balance training i group with focus on core stability exercises and dual attention activities.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed multiple sclerosis by a neurologist, being able to walk 100 m with or without walking device, being able to get down on the floor with minor assistance

Exclusion Criteria:

  • No balance deficit here defined as being able to stand still heel-toe for 30 seconds with arms crossed.
  • Ongoing relapse, cognitive- or language difficulties that prohibits performing the outcome measures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582126

Locations
Sweden
Mälarsjukhuset
Eskilstuna, Sweden, 63188
Karlstad hospital
Karlstad, Sweden
Rörelse och hälsa neuro
Linköping, Sweden
Primärvård Mjölby
Mjölby, Sweden
Nyköpings hospital
Nyköping, Sweden
Västerås hospital
Västerås, Sweden, 72189
University Hospital Örebro
Örebro, Sweden, 70185
Sponsors and Collaborators
Örebro County Council
Regional Research council in the Örebro-Uppsala region
Investigators
Study Chair: Anette Forsberg, PhD Family Medicine Research Centre, Örebro county council
Principal Investigator: Ylva Nilsagård, PhD Centre for Health Care Sciences, Örebro county council
  More Information

No publications provided

Responsible Party: Anette Forsberg, PhD, Researcher, RPT, Örebro County Council
ClinicalTrials.gov Identifier: NCT01582126     History of Changes
Other Study ID Numbers: Ö-1-12
Study First Received: April 16, 2012
Last Updated: March 27, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Örebro County Council:
multiple sclerosis
physical therapy
postural control

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014