Suspended

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

What is being tested

Ankle foot orthosis

Device

Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

From 50 to 75 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: December 2012

See protocol details

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center

Last updated: August 3, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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).

NCT01798927

Principal SponsorUniversity of Texas Southwestern Medical Center

Last updated: August 3, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesNeurodegenerative DiseasesParkinsonian DisordersParkinson Disease

Criteria

6 inclusion criteria required to participate

Ability to walk 150 feet independently over level surfaces with or without an assistive device

Between the ages of 50 and 75

Confirmed diagnosis of Parkinson's Disease

Obvious gait dysfunction (Observational Gait Analysis)

Show More Criteria

3 exclusion criteria prevent from participating

Any other uncontrolled health condition for which gait training is contraindicated

Body mass index of greater than 35

Dorsiflexion range of motion less than neutral (90 degrees)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

UT Southwestern Medical Center, School of Health Professions

Dallas, United StatesOpen UT Southwestern Medical Center, School of Health Professions in Google Maps

SuspendedOne Study Center