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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Therapeutic Exercise Program; Behavioral: Therapeutic Challenge Program

• Registration Number: NCT02524483
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study Start: 2014-10-01
• Primary Completion: 2015-06-01
• Study Completion: 2015-06-01
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Exercise Group	Therapeutic Exercise Program	The Therapeutic Exercise Group will complete the Therapeutic Exercise Program twice a day, five days each week for 6 weeks.
Therapeutic Challenge Group	Therapeutic Challenge Program	The Therapeutic Challenge Group will complete the Therapeutic Challenge Program twice a day, five days each week for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in Balance Using the Sensory Organization Test	Baseline and 6 weeks	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	Baseline and 6 weeks	The changes in walking velocity, step lengths, step widths, and cadence will be quantified using a GaitRITE digital mat.

Secondary Outcome Measures

Name	Time	Method
Changes in Endurance using the 6-Minute Walk	Baseline and 6 weeks	The changes in endurance will be evaluated using the total distance walking during a 6 minute time frame.

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center, Monroe-Meyer Institute; 🇺🇸 Omaha, Nebraska, United States