Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Challenge Program
Therapeutic Exercise Program
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Definitive diagnosis of multiple sclerosis
- Kurtzke Expanded Disability Status of 3.0 - 6.5
- Able to walk on a treadmill at a minimum of 0.5 miles per hour while holding onto handrails
- Cognitively and emotionally competent
- A Mini-Mental State Examination score > 21
- Composite score on the computerized Sensory Organization Test of < 70
Exclusion Criteria:
- Documented MS-related relapse in the previous 6 months
- Major MS-specific medication changes within the previous 3 months
- Presence of another major co-morbidity such as neurological disorders, uncontrolled pain, hypertension, and diabetes
Sites / Locations
- Unversity of Nebraska Medical Center, Monroe-Meyer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Therapeutic Challenge Group
Therapeutic Exercise Group
Arm Description
The Therapeutic Challenge Group will complete the Therapeutic Challenge Program twice a day, five days each week for 6 weeks.
The Therapeutic Exercise Group will complete the Therapeutic Exercise Program twice a day, five days each week for 6 weeks.
Outcomes
Primary Outcome Measures
Changes in Balance Using the Sensory Organization Test
The Sensory Organization Test consists of six different conditions that measure each subject's ability to integrate visual, somatosensory, and vestibular feedback to reduce the overall amount of postural sway and improve balance.
Changes in Walking Velocity, Step Lengths, Step Widths, and Cadence
The changes in walking velocity, step lengths, step widths, and cadence will be quantified using a GaitRITE digital mat.
Secondary Outcome Measures
Changes in Endurance using the 6-Minute Walk
The changes in endurance will be evaluated using the total distance walking during a 6 minute time frame.
Full Information
NCT ID
NCT02524483
First Posted
August 11, 2015
Last Updated
August 30, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT02524483
Brief Title
Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis
Official Title
Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis Influence of High-Dosage Physical Therapy on the Balance and Mobility of Individuals With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
June 1, 2015 (Actual)
Study Completion Date
June 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
5. Study Description
Brief Summary
Outcomes from the investigators' recent investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically improvements in the postural balance and walking speed of individuals with MS.
This investigation will evaluate mobility and postural balance improvements in individuals with MS who participate in a therapeutic protocol consisting of activity based exercises, and in individuals with MS that participate in challenging physical therapy protocol.
Detailed Description
Background: Outcomes from the investigators' recent exploratory investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically relevant improvements in the postural balance and walking speed of individuals with MS.
Objective: The investigators anticipated that the promising results were due to the novel challenging postural balance and mobility exercises. The purpose of this investigation was to test this notion by evaluating the mobility and postural balance improvements that could be achieved in a cohort of individuals with MS who participated in a therapeutic protocol that consisted of activity based exercises, and a cohort of individuals with MS that participated in the challenging physical therapy protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Challenge Group
Arm Type
Experimental
Arm Description
The Therapeutic Challenge Group will complete the Therapeutic Challenge Program twice a day, five days each week for 6 weeks.
Arm Title
Therapeutic Exercise Group
Arm Type
Active Comparator
Arm Description
The Therapeutic Exercise Group will complete the Therapeutic Exercise Program twice a day, five days each week for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Challenge Program
Intervention Description
The Therapeutic Challenge Program will consist of a 5 minute warm-up, 20 minutes of challenging balance training, and 20 minutes of challenging treadmill and overground walking.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Exercise Program
Intervention Description
The Therapeutic Exercise Program will consist of 15 minutes of strength training and flexibility exercises, 15 minutes of balance exercises, and 15 minutes of treadmill walking.
Primary Outcome Measure Information:
Title
Changes in Balance Using the Sensory Organization Test
Description
The Sensory Organization Test consists of six different conditions that measure each subject's ability to integrate visual, somatosensory, and vestibular feedback to reduce the overall amount of postural sway and improve balance.
Time Frame
Baseline and 6 weeks
Title
Changes in Walking Velocity, Step Lengths, Step Widths, and Cadence
Description
The changes in walking velocity, step lengths, step widths, and cadence will be quantified using a GaitRITE digital mat.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Changes in Endurance using the 6-Minute Walk
Description
The changes in endurance will be evaluated using the total distance walking during a 6 minute time frame.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Definitive diagnosis of multiple sclerosis
Kurtzke Expanded Disability Status of 3.0 - 6.5
Able to walk on a treadmill at a minimum of 0.5 miles per hour while holding onto handrails
Cognitively and emotionally competent
A Mini-Mental State Examination score > 21
Composite score on the computerized Sensory Organization Test of < 70
Exclusion Criteria:
Documented MS-related relapse in the previous 6 months
Major MS-specific medication changes within the previous 3 months
Presence of another major co-morbidity such as neurological disorders, uncontrolled pain, hypertension, and diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max J Kurz, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center, Monroe-Meyer Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27373745
Citation
Davies BL, Arpin DJ, Liu M, Reelfs H, Volkman KG, Healey K, Zabad R, Kurz MJ. Two Different Types of High-Frequency Physical Therapy Promote Improvements in the Balance and Mobility of Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Dec;97(12):2095-2101.e3. doi: 10.1016/j.apmr.2016.05.024. Epub 2016 Jul 1.
Results Reference
derived
Learn more about this trial
Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis
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