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

NCT01798927 | Terminated Results

• 1 other identifier: PD AFO
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; ankle foot orthosis (AFO); gait

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing

  Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment

Study Arms (1)

Ankle foot orthosis fitting

OTHER

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

Device: Ankle foot orthosis

Interventions

Ankle foot orthosis DEVICE

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

Also known as: Tamarack with check strap

Ankle foot orthosis fitting

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center, School of Health Professions

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Karen McCain, PT, DPT, NCS
• Organization: UT Southwestern Medical Center

karen.mccain@utsouthwestern.edu

214-648-1559

Study Officials

• Karen J McCain, DPT

  UTSW Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 26, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 3, 2015
• Results First Posted: August 3, 2015

Record last verified: 2015-07

Locations

US (1)