Clinical trial NCT02524483: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Balance Using the Sensory Organization Test
timeFrame: Baseline and 6 weeks
measure: Changes in Walking Velocity, Step Lengths, Step Widths, and Cadence
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Changes in Endurance using the 6-Minute Walk
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center, Monroe-Meyer Institute
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Max J Kurz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.