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The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT01947582
Recruitment Status : Completed
First Posted : September 20, 2013
Results First Posted : June 1, 2015
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
Karen McCain, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3. Individuals who are fit with an AFO will demonstrate improvements in muscle firing profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements in quality of life.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Ankle foot orthosis Not Applicable

Detailed Description:
This is a non-randomized, single group (N=15), repeated measures study. The outcome measure for the study include: 1. GAITRite System for step length, 2. EMG of the anterior tibialis, gastrocnemius, soleus, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. 12-Item MS Walking Scale (Quality of Life assessment). This study will be 24 weeks long. Over the 24-week period, the subject will participate in 14 gait training sessions which will be at weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 17, 20 and 23. The treatments will be 45-60 minutes in duration. Outcome measures (all or part) will be assessed at the following times: initial (T1), week 5 (T2), week 13 (T3), and week 24 (T4). Subjects will be closely monitored throughout the 24 week study and will be un-enrolled by self-request or the following medical reasons: 1. Acute exacerbation of MS symptoms, 2. New diagnosis with direct consequences affecting gait training, 3. Inability to tolerate the AFO.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Application of ankle foot orthosis
All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
 Device: Ankle foot orthosis
The ankle foot orthoses (AFOs) that will be used are designed to provide assistance with anterior tibial advancement during stance and dorsi flexion assistance during swing. The device(s) are polypropylene and are custom-fabricated.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Walking Distance During 6-Minute Walk Test [ Time Frame: Assessed at visit 2 (week 1) and week 24 ]
    Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.


Secondary Outcome Measures :
  1. Change in Impact of MS on Fatigue Using the 12-Item Walk Scale [ Time Frame: Assessed at visit 2 (week 1) and week 24 ]
    The 12-Item Walk Scale is a paper and pencil test that asks persons with MS to rate their level of fatigue when doing functional tasks. The maximum possible score is 60 points and the lowest possible score is 12. Higher scores indicate a greater impact on walking than lower scores.

  2. Change in Step Length Using the GAITRite Computerized Gait Analysis System [ Time Frame: Assessed at visit 2 (week 1) and week 24 ]
    Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.

  3. Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG) [ Time Frame: Assessed at visit 2 (week 1) and week 24 ]
    Surface EMG is done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius, soleus) during computerized gait assessment. Changes in amplitude of muscle activity or timing of muscle activity would indicate, for example, increases in strength or changes in timing of muscles which might indicate motor learning as a result of wearing the ankle foot orthosis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with a primary diagnosis of multiple sclerosis
  • Individuals who are able to maintain a walking velocity of 30 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
  • Could have current or past history of single or bilateral AFO use, including neuroprostheses
  • Evidence of weakness in plantarflexors

Exclusion Criteria:

  • The presence of co-morbidities (neuromuscular or musculoskeletal) that would negatively impact gait training
  • Individuals with BMI with >/= 40kg/m2
  • Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
  • Individuals that plan to begin the use of Ampyra during the course of the study
  • Individuals for whom the cost of an orthosis would represent a financial burden
  • Individuals who are receiving concurrent physical therapy services elsewhere
  • MSNQ of >22
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947582


Locations
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United States, Texas
UT Southwestern Medical Center School of Health Professions
Dallas, Texas, United States, 75223
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Karen J McCain, PT, DPT, NCS University of Texas Southwestern Medical Center
More Information
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Responsible Party: Karen McCain, Associate Professor, School of Health Professions, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01947582    
Other Study ID Numbers: MS Bracing
First Posted: September 20, 2013    Key Record Dates
Results First Posted: June 1, 2015
Last Update Posted: March 7, 2016
Last Verified: February 2016
Keywords provided by Karen McCain, University of Texas Southwestern Medical Center:
multiple sclerosis
gait
ankle foot orthosis (AFO)
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases