Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis



Status:Terminated
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:21 - 60
Updated:4/21/2016
Start Date:September 2012
End Date:August 2013

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The Impact of Ankle Foot Orthosis (AFO) on Gait Recovery in Select Individuals With Multiple Sclerosis (MS)

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.

This is a non-randomized, single group (N=15), repeated measures study. The study will take
place at the David M. Crowley Research and Rehabilitation Lab in the School of Health
Professions at University of Texas Southwestern Medical Center. The outcome measures for the
study include: 1. GAITRite System for temporal and spatial parameters, 2. EMG of the
anterior tibialis, gastrocnemius, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait
endurance) 4. Lower extremity strength, 5. MS Fatigue scale, 6. Observational Gait Analysis
- Video tape of over ground walking. This study will be 13 weeks long. Over the 13 week
period, the subject will participate in 5 gait training sessions which will be at weeks 1,
2, 3, 7, and 10. They will be 60 minutes in duration. Outcome measures will be assessed at
the following times: initial (T1), week 5 (T2), and week 13 (T3). Subjects will be closely
monitored throughout the 13 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 study AFO.

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
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