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Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AFO
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 Gait, AFO, MS

Eligibility Criteria

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

Sites / Locations

  • University of Texas Southwestern Medical Center, School of Health Professions

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AFO

Arm Description

All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).

Outcomes

Primary Outcome Measures

Change in Step Length From Initial Testing to End of Study
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.

Secondary Outcome Measures

Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing
Surface electromyography will be done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in muscle activity would be things like large changes in amplitude of muscle firing or changes in the timing of muscle firing, for example. These would indicate changes in strength or perhaps motor learning as a result of wearing the ankle foot orthosis.

Full Information

First Posted
February 18, 2013
Last Updated
August 3, 2015
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01796860
Brief Title
Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis
Official Title
The Impact of Ankle Foot Orthosis (AFO) on Gait Recovery in Select Individuals With Multiple Sclerosis (MS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Modifications were made to protocol, new IRB pending
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (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
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Gait, AFO, MS

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
AFO
Arm Type
Other
Arm Description
All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).
Intervention Type
Other
Intervention Name(s)
AFO
Intervention Description
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. 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.
Primary Outcome Measure Information:
Title
Change in Step Length From Initial Testing to End of Study
Description
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
Time Frame
Computerized gait analysis will be done at the time of enrollment and week 13.
Secondary Outcome Measure Information:
Title
Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing
Description
Surface electromyography will be done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in muscle activity would be things like large changes in amplitude of muscle firing or changes in the timing of muscle firing, for example. These would indicate changes in strength or perhaps motor learning as a result of wearing the ankle foot orthosis.
Time Frame
Surface EMG will be done at the time of enrollment and week 13.
Other Pre-specified Outcome Measures:
Title
Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing
Description
Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices as necessary.
Time Frame
6MWT will be done at the time of enrollment and week 13.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 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 >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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen McCain, DPT
Organizational Affiliation
UTSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center, School of Health Professions
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis

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