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

Parkinson's Disease Clinical Trial

Official title:

Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01798927
• Other study ID #: PD AFO
• Status: Terminated
• Phase: N/A
• First received: February 11, 2013
• Last updated: July 6, 2015
• Start date: December 2012
• Est. completion date: July 2013

Study information

• Verified date: July 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 Parkinson's disease.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	UT 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 by Use of 6-Minute Walk Test From Initial 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 if necessary.	Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment	No
Primary	Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing	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.	Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment	No
Secondary	Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing	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.	Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.	No