N/A
Completed N=2
The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
Source: ClinicalTrials.gov NCT01947582 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Change in Walking Distance During 6-Minute Walk Test — 222 feet
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Walking Distance During 6-Minute Walk Test |
222 | — |
| SECONDARY Change in Impact of MS on Fatigue Using the 12-Item Walk Scale |
1 | — |
| SECONDARY Change in Step Length Using the GAITRite Computerized Gait Analysis System |
3.3 | — |
| SECONDARY Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG) |
1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01947582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.