Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01796860
• Other study ID #: MS AFO
• Status: Terminated
• Phase: N/A
• First received: February 18, 2013
• Last updated: August 3, 2015
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2015
• 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas 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
Other	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.	No
Primary	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.	No
Secondary	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.	No