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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Therapeutic Challenge Program; Behavioral: Therapeutic Exercise Program

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • Unversity of Nebraska Medical Center, Monroe-Meyer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Max J Kurz, PhD, University of Nebraska

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimated): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 0467-14-EP