Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis

The Impact of Ankle Foot Orthosis (AFO) on Gait Recovery in Select Individuals With Multiple Sclerosis (MS)

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: AFO

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center, School of Health Professions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: AFO; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Computerized gait analysis will be done at the time of enrollment and week 13.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Surface EMG will be done at the time of enrollment and week 13.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing	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.	6MWT will be done at the time of enrollment and week 13.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Karen McCain, DPT, UTSW

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 18, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Estimate): August 21, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: MS; Gait; AFO
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MS AFO