The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)

The University of Texas System (UT)

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Device: Ankle foot orthosis

Study type

Interventional

Funder types

Other

Identifiers

NCT01947582

MS Bracing

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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