Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis
The Impact of Ankle Foot Orthosis (AFO) on Gait Recovery in Select Individuals With Multiple Sclerosis (MS)
What it found
The trial ended early for another reason (see below).
Reason given: Modifications were made to protocol, new IRB pending
What was tested
Treatment tested
- AFO
Results by group
Change in Step Length From Initial Testing to End of Study
Computerized gait analysis will be done at the time of enrollment and week 13.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ankle Foot Orthosis Group | 6.47 measure of length (cm) | 3.26 (Standard Deviation) | 7 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Ankle Foot Orthosis Group | 7 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Step Length From Initial Testing to End of Study
Computerized gait analysis will be done at the time of enrollment and week 13.
Walking and mobility
Other measures (1)
Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing
Surface EMG will be done at the time of enrollment and week 13.
Walking and mobilityPhysical function
Who could take part
MS (type not specified) · 21 to 60
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Sept 2012
Main results due
Aug 2013
Finished
Aug 2013
Results posted
Aug 2015