Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis

NCT ID: NCT01796860

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-08-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AFO

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

Group Type: OTHER

AFO

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Karen McCain

Assistant Professor, School of Health Professions

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen McCain, DPT

Role: PRINCIPAL_INVESTIGATOR

UTSW

Locations

University of Texas Southwestern Medical Center, School of Health Professions

Dallas, Texas, United States

Countries

United States

Other Identifiers

MS AFO

Identifier Type: -

Identifier Source: org_study_id