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

• ClinicalTrials.gov Identifier: NCT01798927
• Recruitment Status: Terminated
• First Posted: February 26, 2013
• Results First Posted: August 3, 2015
• Last Update Posted: August 3, 2015
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Karen McCain, University of Texas Southwestern Medical Center

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 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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Karen J McCain, DPT; UTSW Medical Center

More Information

• Responsible Party: Karen McCain, Assistant Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01798927
• Other Study ID Numbers: PD AFO
• First Posted: February 26, 2013
• 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); gait

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases