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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524483
• Other study ID #: 0467-14-EP
• Status: Completed
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: June 1, 2015

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 1, 2015
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Therapeutic Challenge Program
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.
• Therapeutic Exercise Program
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.

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center, Monroe-Meyer Institute	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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