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Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01798927
Recruitment Status : Terminated (Modifications are being made to protocol)
First Posted : February 26, 2013
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Information provided by (Responsible Party):
Karen McCain, University of Texas Southwestern Medical Center

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 Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Ankle foot orthosis Not Applicable

Detailed Description:
This study will be 10 weeks long. Following fitting with unilateral or bilateral custom-fabricated AFOs the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. Each training session will be 45-60 minutes in duration. Various outcome measures will be completed at the following times: time of consent (T1), treatment 1 at time of brace delivery (T2), week 5 (T3), and week 10 (T4). Subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. New diagnosis with direct consequences affecting gait training, 2. Inability to tolerate the study AFO(s).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.
Study Start Date : December 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Ankle foot orthosis fitting
All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Device: Ankle foot orthosis
Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Other Name: Tamarack with check strap

Primary Outcome Measures :
  1. Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing [ Time Frame: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment ]
    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 :
  1. Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing [ Time Frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment. ]
    Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.

Other Outcome Measures:
  1. Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing [ Time Frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment ]
    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 if necessary.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of Parkinson's Disease
  • Between the ages of 50 and 75
  • Ability to walk 150 feet independently over level surfaces with or without an assistive device
  • Stable medication usage for the duration of the study (10 weeks)
  • Obvious gait dysfunction (Observational Gait Analysis)
  • Score of greater than 22 on the Short Orientation-Memory-Concentration Test

Exclusion Criteria:

  • Body mass index of greater than 35
  • Dorsiflexion range of motion less than neutral (90 degrees)
  • Any other uncontrolled health condition for which gait training is contraindicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01798927

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United States, Texas
UT Southwestern Medical Center, School of Health Professions
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Karen J McCain, DPT UTSW Medical Center
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Responsible Party: Karen McCain, Assistant Professor, University of Texas Southwestern Medical Center Identifier: NCT01798927    
Other Study ID Numbers: PD AFO
First Posted: February 26, 2013    Key Record Dates
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015
Last Verified: July 2015
Keywords provided by Karen McCain, University of Texas Southwestern Medical Center:
Parkinson's disease
ankle foot orthosis (AFO)
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases