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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Strength training and treadmill training
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Walking ability, Strength, Balance, Treadmill walking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treadmill group

Strength training group

Arm Description

Specific gait training on treadmill

Eight weeks of intensive strength training

Outcomes

Primary Outcome Measures

Walking ability

Secondary Outcome Measures

Strength
Work economy O2
Balance

Full Information

First Posted
February 23, 2010
Last Updated
July 6, 2015
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Helse Midt-Norge
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1. Study Identification

Unique Protocol Identification Number
NCT01074827
Brief Title
Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?
Official Title
Strength Training or Treadmill Walking? A Randomized Control Study on the Effect on Gait in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Helse Midt-Norge

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Walking ability, Strength, Balance, Treadmill walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill group
Arm Type
Experimental
Arm Description
Specific gait training on treadmill
Arm Title
Strength training group
Arm Type
Experimental
Arm Description
Eight weeks of intensive strength training
Intervention Type
Other
Intervention Name(s)
Strength training and treadmill training
Intervention Description
Eight weeks of intensive strength training or treadmill training
Primary Outcome Measure Information:
Title
Walking ability
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Strength
Time Frame
8 weeks
Title
Work economy O2
Time Frame
8 weeks
Title
Balance
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siri M, Brændvik
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26110230
Citation
Braendvik SM, Koret T, Helbostad JL, Loras H, Brathen G, Hovdal HO, Aamot IL. Treadmill Training or Progressive Strength Training to Improve Walking in People with Multiple Sclerosis? A Randomized Parallel Group Trial. Physiother Res Int. 2016 Dec;21(4):228-236. doi: 10.1002/pri.1636. Epub 2015 Jun 25.
Results Reference
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Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?

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