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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ankle foot orthosis fitting

All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.

Group Type OTHER

Ankle foot orthosis

Intervention Type DEVICE

Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Tamarack with check strap

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No