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OpenTrials
Completed

NCT Number: NCT02524483

Influence of Exercise on the Mobility and Balance 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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unversity of Nebraska Medical Center, Monroe-Meyer Institute

Omaha, Nebraska, 68106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic Challenge Program

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 Program

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.

Primary outcomes

  1. Changes in Balance Using the Sensory Organization Test

    Time frame: 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.

  2. Changes in Walking Velocity, Step Lengths, Step Widths, and Cadence

    Time frame: Baseline and 6 weeks

    The changes in walking velocity, step lengths, step widths, and cadence will be quantified using a GaitRITE digital mat.

Secondary outcomes

  1. Changes in Endurance using the 6-Minute Walk

    Time frame: Baseline and 6 weeks

    The changes in endurance will be evaluated using the total distance walking during a 6 minute time frame.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2015
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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