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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947582
• Other study ID #: MS Bracing
• Status: Completed
• Phase: N/A
• First received: September 17, 2013
• Last updated: February 4, 2016
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center School of Health Professions	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Walking Distance During 6-Minute Walk Test	Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.	Assessed at visit 2 (week 1) and week 24	No
Secondary	Change in Impact of MS on Fatigue Using the 12-Item Walk Scale	The 12-Item Walk Scale is a paper and pencil test that asks persons with MS to rate their level of fatigue when doing functional tasks. The maximum possible score is 60 points and the lowest possible score is 12. Higher scores indicate a greater impact on walking than lower scores.	Assessed at visit 2 (week 1) and week 24	No
Secondary	Change in Step Length Using the GAITRite Computerized Gait Analysis System	Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.	Assessed at visit 2 (week 1) and week 24	No
Secondary	Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)	Surface EMG is done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius, soleus) during computerized gait assessment. Changes in amplitude of muscle activity or timing of muscle activity would indicate, for example, increases in strength or changes in timing of muscles which might indicate motor learning as a result of wearing the ankle foot orthosis.	Assessed at visit 2 (week 1) and week 24	No