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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle foot orthosis
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, gait, ankle foot orthosis (AFO)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • UT Southwestern Medical Center School of Health Professions

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Application of ankle foot orthosis

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 17, 2013
Last Updated
February 4, 2016
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01947582
Brief Title
The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
Official Title
The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, gait, ankle foot orthosis (AFO)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Application of ankle foot orthosis
Arm Type
Other
Arm Description
All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Intervention Type
Device
Intervention Name(s)
Ankle foot orthosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Walking Distance During 6-Minute Walk Test
Description
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.
Time Frame
Assessed at visit 2 (week 1) and week 24
Secondary Outcome Measure Information:
Title
Change in Impact of MS on Fatigue Using the 12-Item Walk Scale
Description
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.
Time Frame
Assessed at visit 2 (week 1) and week 24
Title
Change in Step Length Using the GAITRite Computerized Gait Analysis System
Description
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.
Time Frame
Assessed at visit 2 (week 1) and week 24
Title
Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)
Description
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.
Time Frame
Assessed at visit 2 (week 1) and week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J McCain, PT, DPT, NCS
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center School of Health Professions
City
Dallas
State/Province
Texas
ZIP/Postal Code
75223
Country
United States

12. IPD Sharing Statement

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

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