Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis

The University of Texas System (UT)

Status

Terminated

Conditions

Multiple Sclerosis

Treatments

Other: AFO

Study type

Interventional

Funder types

Other

Identifiers

NCT01796860

MS AFO

Details and patient eligibility

About

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.

Full description

This is a non-randomized, single group (N=15), repeated measures study. The study will take place at the David M. Crowley Research and Rehabilitation Lab in the School of Health Professions at University of Texas Southwestern Medical Center. The outcome measures for the study include: 1. GAITRite System for temporal and spatial parameters, 2. EMG of the anterior tibialis, gastrocnemius, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. Lower extremity strength, 5. MS Fatigue scale, 6. Observational Gait Analysis - Video tape of over ground walking. This study will be 13 weeks long. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10. They will be 60 minutes in duration. Outcome measures will be assessed at the following times: initial (T1), week 5 (T2), and week 13 (T3). Subjects will be closely monitored throughout the 13 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 study AFO.

Enrollment

10 patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

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