Clinical trial NCT01796860: Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis
Official title: The Impact of Ankle Foot Orthosis (AFO) on Gait Recovery in Select Individuals With Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Gait
AFO
MS
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing
timeFrame: Surface EMG will be done at the time of enrollment and week 13.
Other outcomes:
measure: Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing
timeFrame: 6MWT will be done at the time of enrollment and week 13.
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, School of Health Professions
state: Texas
Study officials:
affiliation: UTSW
name: Karen McCain, DPT
role: PRINCIPAL_INVESTIGATOR
References: