TerminatedNot Applicable

Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis

Stopped: Modifications were made to protocol, new IRB pending

United States10 participantsStarted 2012-09

Plain-language summary

The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. This orthotic is fabricated to allow ankle range of motion required for normal gait kinematics. Additionally, it controls forward progression of the tibia during the stance phase of gait. This study has three hypotheses 1. Individuals who are fit with the AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with the AFO will demonstrate improvements in walking endurance, and 3. Individuals who are fit with the AFO will demonstrate improvements in muscle firing profiles/EMG measures.

Who can participate

Age range21 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals with a primary diagnosis of multiple sclerosis * Individuals \>21 and \<60 years old * Individuals who are able to maintain a walking velocity of 60 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device. * 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 \>/= 35kg/m2 * Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion * Individuals that will 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, * Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) of \>22 * Individuals for whom bilateral AFOs are indicated, but have different design

What they're measuring

Change in Step Length From Initial Testing to End of Study

Timeframe: Computerized gait analysis will be done at the time of enrollment and week 13.

Trial details

NCT IDNCT01796860

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

Results submitted2015-05-13