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

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ClinicalTrials.gov Identifier: NCT01798927
Recruitment Status : Terminated (Modifications are being made to protocol)
First Posted : February 26, 2013
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Karen McCain, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE February 11, 2013
First Posted Date  ICMJE February 26, 2013
Results First Submitted Date  ICMJE May 13, 2015
Results First Posted Date  ICMJE August 3, 2015
Last Update Posted Date August 3, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Change in gait parameters by means of computerized gait analysis [ Time Frame: Done at time of enrollment, week 5, week 10 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 temporal and spatial gait parameters.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2015)
Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing [ Time Frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment. ]
Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Change in electromyography of key lower extremity muscles [ Time Frame: Done at time of enrollment, week 5, week 10 post enrollment. ]
Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment.
Current Other Pre-specified Outcome Measures
 (submitted: July 6, 2015)
Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing [ Time Frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment ]
Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
Original Other Pre-specified Outcome Measures
 (submitted: February 21, 2013)
Change in walking endurance by use of 6-Minute Walk Test [ Time Frame: Done at time of enrollment, week 5, week 10 post enrollment ]
Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
 
Descriptive Information
Brief Title  ICMJE Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease
Official Title  ICMJE Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Device: 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.
Other Name: Tamarack with check strap
Study Arms  ICMJE Ankle foot orthosis fitting
All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Intervention: Device: Ankle foot orthosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 21, 2013)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2013)
10
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01798927
Other Study ID Numbers  ICMJE PD AFO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karen McCain, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen J McCain, DPT UTSW Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP