NCT02524483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

August 11, 2015

Last Update Submit

August 30, 2023

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Changes in Endurance using the 6-Minute Walk

    Baseline and 6 weeks

Study Arms (2)

Therapeutic Challenge Group

EXPERIMENTAL

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

Behavioral: Therapeutic Challenge Program

Therapeutic Exercise Group

ACTIVE COMPARATOR

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

Therapeutic Challenge ProgramBEHAVIORAL

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 Challenge Group
Therapeutic Exercise ProgramBEHAVIORAL

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.

Therapeutic Exercise Group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Nebraska Medical Center, Monroe-Meyer Institute

Omaha, Nebraska, 68106, United States

Location

Related Publications (1)

  • 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.

    PMID: 27373745DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Max J Kurz, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 14, 2015

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

US(1)