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Clinical Trials/NCT01798927
NCT01798927
Terminated
N/A

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

University of Texas Southwestern Medical Center1 site in 1 country4 target enrollmentDecember 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
University of Texas Southwestern Medical Center
Enrollment
4
Locations
1
Primary Endpoint
Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing
Status
Terminated
Last Updated
10 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
July 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen McCain

Assistant Professor

University of Texas Southwestern Medical Center

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing(Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.)

Study Sites (1)

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