The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | December 2014 |
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.
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.
This is a non-randomized, single group (N=15), repeated measures study. The outcome measure
for the study include: 1. GAITRite System for step length, 2. EMG of the anterior tibialis,
gastrocnemius, soleus, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance)
4. 12-Item MS Walking Scale (Quality of Life assessment). This study will be 24 weeks long.
Over the 24-week period, the subject will participate in 14 gait training sessions which
will be at weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 17, 20 and 23. The treatments will be
45-60 minutes in duration. Outcome measures (all or part) will be assessed at the following
times: initial (T1), week 5 (T2), week 13 (T3), and week 24 (T4). Subjects will be closely
monitored throughout the 24 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 AFO.
for the study include: 1. GAITRite System for step length, 2. EMG of the anterior tibialis,
gastrocnemius, soleus, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance)
4. 12-Item MS Walking Scale (Quality of Life assessment). This study will be 24 weeks long.
Over the 24-week period, the subject will participate in 14 gait training sessions which
will be at weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 17, 20 and 23. The treatments will be
45-60 minutes in duration. Outcome measures (all or part) will be assessed at the following
times: initial (T1), week 5 (T2), week 13 (T3), and week 24 (T4). Subjects will be closely
monitored throughout the 24 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 AFO.
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
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