The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With
The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Ankle foot orthosis
Results by group
Change in Walking Distance During 6-Minute Walk Test
Assessed at visit 2 (week 1) and week 24
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Application of Ankle Foot Orthosis | 222 feet | 1 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Application of Ankle Foot Orthosis | 2 | 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 Walking Distance During 6-Minute Walk Test
Assessed at visit 2 (week 1) and week 24
Walking and mobility
Other measures (3)
Change in Impact of MS on Fatigue Using the 12-Item Walk Scale
Assessed at visit 2 (week 1) and week 24
FatigueWalking and mobilityChange in Step Length Using the GAITRite Computerized Gait Analysis System
Assessed at visit 2 (week 1) and week 24
Walking and mobilityNumber of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)
Assessed at visit 2 (week 1) and week 24
Walking and mobilityPhysical function
Who could take part
MS (type not specified) · 18 to 60
Show the full 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
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 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.
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History
Started
Oct 2013
Main results due
Dec 2014
Finished
Dec 2014
Results posted
Jun 2015