Clinical trial NCT01798927: Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease
Official title: Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
ankle foot orthosis (AFO)
gait
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing
timeFrame: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment
Secondary outcomes:
measure: Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing
timeFrame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.
Other outcomes:
measure: Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing
timeFrame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center, School of Health Professions
state: Texas
Study officials:
affiliation: UTSW Medical Center
name: Karen J McCain, DPT
role: PRINCIPAL_INVESTIGATOR
References: