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Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?

This study has been completed.
Sponsor:
Collaborators:
Sør-Trøndelag University College
Helse Midt-Norge
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01074827
First received: February 23, 2010
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

The objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.


Condition Intervention
Multiple Sclerosis
 Other: Strength training and treadmill training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strength Training or Treadmill Walking? A Randomized Control Study on the Effect on Gait in Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Walking ability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Strength [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Work economy O2 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Balance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treadmill group
Specific gait training on treadmill
 Other: Strength training and treadmill training
Eight weeks of intensive strength training or treadmill training
Experimental: Strength training group
Eight weeks of intensive strength training
 Other: Strength training and treadmill training
Eight weeks of intensive strength training or treadmill training

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with Multiple Sclerosis,classified as relapsing remitting,or primary/secondary progressive
  • Expanded Disability Status Scale (EDSS)score of ≤ 6
  • Reduced walking ability (subjectively experienced)

Exclusion Criteria:

  • persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training.
  • spasticity requiring stretching og treatment with baclofen.
  • Other, not MS-related, conditions affecting walking ability.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074827

Locations
Norway
St. Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Sør-Trøndelag University College
Helse Midt-Norge
Investigators
Study Chair: Siri M, Brændvik St. Olavs Hospital
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01074827     History of Changes
Other Study ID Numbers: 09/225
Study First Received: February 23, 2010
Last Updated: February 8, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by St. Olavs Hospital:
Multiple Sclerosis
Walking ability
Strength
Balance
Treadmill walking

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

ClinicalTrials.gov processed this record on May 16, 2013