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CompletedNCT02524483Updated Sep 5, 2023

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

An interventional study of Therapeutic Challenge Program and Therapeutic Exercise Program in Multiple Sclerosis, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2014, registered Aug 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralTherapeutic 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.

  • BehavioralTherapeutic 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 6 weeks

  2. 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.

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and 6 weeks

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Study locations

1 site
  • Unversity of Nebraska Medical Center, Monroe-Meyer Institute
    Omaha, Nebraska 68106, United States
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References and documents

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. PubMed 27373745 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02524483
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Aug 14, 2015
Start date
Oct 1, 2014
Primary completion
Jun 1, 2015
Completion
Jun 1, 2015
Last update
Sep 5, 2023

Study contacts

Max J Kurz, PhD
principal investigator · University of Nebraska
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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