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

NCT ID: NCT02524483

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-01

Study Completion Date

2015-06-01

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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapeutic Challenge Group

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

Group Type EXPERIMENTAL

Therapeutic Challenge Program

Intervention Type BEHAVIORAL

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 Group

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

Group Type ACTIVE_COMPARATOR

Therapeutic Exercise Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Max J Kurz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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Unversity of Nebraska Medical Center, Monroe-Meyer Institute

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27373745 (View on PubMed)

Other Identifiers

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0467-14-EP

Identifier Type: -

Identifier Source: org_study_id

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