Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Therapeutic Challenge Program
* Behavioral: Therapeutic Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Challenge Group<br>The Therapeutic Challenge Group will complete the Therapeutic Challenge Program twice a day, five days each week for 6 weeks. | Behavioral: Therapeutic Challenge Program<br>* 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.<br>|
| Active Comparator: Therapeutic Exercise Group<br>The Therapeutic Exercise Group will complete the Therapeutic Exercise Program twice a day, five days each week for 6 weeks. | Behavioral: Therapeutic Exercise Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6 weeks |