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

NCT ID: NCT01947582

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-12-31

Brief 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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Application of ankle foot orthosis

All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.

Group Type: OTHER

Ankle foot orthosis

Intervention Type: DEVICE

The ankle foot orthoses (AFOs) that will be used are designed to provide assistance with anterior tibial advancement during stance and dorsi flexion assistance during swing. The device(s) are polypropylene and are custom-fabricated.

Interventions

Ankle foot orthosis

The ankle foot orthoses (AFOs) that will be used are designed to provide assistance with anterior tibial advancement during stance and dorsi flexion assistance during swing. The device(s) are polypropylene and are custom-fabricated.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Karen McCain

Associate Professor, School of Health Professions

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen J McCain, PT, DPT, NCS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

UT Southwestern Medical Center School of Health Professions

Dallas, Texas, United States

Countries

United States

Other Identifiers

MS Bracing

Identifier Type: -

Identifier Source: org_study_id