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Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by State University of New York - Upstate Medical University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01749657
First received: September 18, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

The lack of high quality evidence to guide conservative care for patients with posterior tibial tendon dysfunction (PTTD) has led to controversy over clinical care. Numerous orthotic devices are available to avoid a costly and debilitating surgery but no consensus on which to use has been made. The current study aims to link biomechanical testing of selected devices to clinical outcomes in subjects with PTTD after wearing a device for 12 weeks.


Condition Intervention
Posterior Tibial Tendon Dysfunction
Device: Arizona

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Foot Function Index - Revised [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The Foot Function Index - Revised (FFI-R) is a newly published version of the original Foot Function Index (FFI) [45]. The original FFI is a validated, disease specific questionnaire that is widely used to measure foot function and document outcomes in observational studies of PTTD [31, 33]. Rasch analyses for the FFI-R indicated a Pearson reliability of 0.96 and item reliability of 0.93. The domains of the 34 items in the FFI-R questionnaire include pain and stiffness, social/emotional issues, personal disability, and social activity limitation. Although the FFI-R is relatively new, the 23 items from the FFI were the basis for the revised scale. The FFI has been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD [32]. The overall score of the FFI-R will be used as a primary outcome variable while the subscales will be used as secondary outcome variables.


Secondary Outcome Measures:
  • Foot and Ankle Ability Measure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assess the self-reported functional outcomes of patients with primarily foot and ankle pain.

  • Ankle Strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Compare strength changes over the 12 week intervention. Strength measures will include isometric and isokinetic testing using a Biodex System 3 strength testing system

  • Hip Strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Compare strength changes over the 12 week intervention. Strength measures will include isometric and isokinetic testing using a Biodex System 3 strength testing system

  • Deep Posterior Compartment Strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Compare deep posterior compartment strength after 12 weeks across the 4 groups in the study


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Off-the-shelf Device and shoe
subjects will wear an off-the-shelf orthotic device (AirLift PTTD Brace) and standard Edge shoe (Aetrex Co) for 12 weeks
Device: Arizona
Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD).
Other Name: Arizona Brace (3 different designs) versus AirLift PTTD Brace (DJ Orthopedics - AirCast Co)
Experimental: Custom Device - standard and Shoe
subjects will wear a custom (standard) orthotic device (Arizona Co) and Edge shoes (Aetrex Co.) for 12 weeks.
Device: Arizona
Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD).
Other Name: Arizona Brace (3 different designs) versus AirLift PTTD Brace (DJ Orthopedics - AirCast Co)
Experimental: Custom Articulated device and Shoe
subjects will wear a custom articulated device (Arizona Co) and Edge shoe (Aetrex Co)for 12 weeks
Device: Arizona
Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD).
Other Name: Arizona Brace (3 different designs) versus AirLift PTTD Brace (DJ Orthopedics - AirCast Co)
Experimental: Custom Extended Device and Shoe
subjects will wear a custom extended foot plate orthotic device (Arizona Co) and Edge shoe (Aetrex Co) for 12 weeks.
Device: Arizona
Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD).
Other Name: Arizona Brace (3 different designs) versus AirLift PTTD Brace (DJ Orthopedics - AirCast Co)

Detailed Description:

Orthotic devices serve as essential elements of conservative care programs for posterior tibial tendon dysfunction (PTTD). Data on currently used devices remain limited. Current device designs are restrictive and focus on correction of flatfoot kinematics in subjects with stage II PTTD. Restrictive designs that limit ankle motion may lead to weakness and altered gait dynamics. It remains unclear if less restrictive device designs would be more optimal for subjects with stage II PTTD. The aims of the current proposal are to examine the in-vivo biomechanics of different device designs and to use outcomes to identify the device and design optimal for subjects with stage II PTTD. Research Design: This study will use a laboratory based repeated measures design to explore the function of four different orthotic devices in a sample of 60 subjects with stage II PTTD at baseline. Then each subject will be followed prospectively for 12 weeks while wearing one of the orthotic devices. Clinical outcomes including strength, tendon morphology, and self-reported outcomes will be measured at 12 weeks. Baseline foot kinematics will be collected using a three segment foot model (first metatarsal, calcaneus, tibia) while data on ankle kinetics will be derived from the kinematic data and the ground reaction forces. Impact: There are currently no head-to-head comparisons available among the various devices used in the conservative management of stage II PTTD. The proposed study will provide the necessary controlled data to determine the kinematic and kinetic effects of selected devices and the specific components needed to optimize device design. Outcomes will be used to determine which designs are successful to use clinically.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria Stage II PTTD

    • Swelling
    • Pain with Palpation along the tendon
    • Rearfoot eversion
    • Pain single leg heel raise
    • Flexible flat foot deformity
    • Able to walk 15 m
    • > 40 years of age

Exclusion Criteria:

  • Unable to walk 15 m
  • Symmes-Weinstein monofilament test 5.06 mm
  • Inflammatory arthropathies (e.g. rheumatoid arthritis, psoriasis)
  • Co-morbid foot conditions (e.g. hallux rigidis, plantar fasciitis)
  • Inability to assume a STN posture
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749657

Contacts
Contact: Christopher G Neville, PhD, PT 315-464-9966 nevillec@upstate.edu
Contact: Judy Ziobrowski 315-464-6881 ziobrowj@upstate.edu

Locations
United States, New York
Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Principal Investigator: Christopher G Neville, PhD, PT         
Sub-Investigator: Frederick R Lemley, MD         
Sub-Investigator: Gary Brooks, PT, DrPH         
Sub-Investigator: Nathaniel Ordway, MS, PE         
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Christopher G Neville, PhD Upstate Medical University
  More Information

Publications:
Responsible Party: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01749657     History of Changes
Other Study ID Numbers: 1R15AR061737-01A1, 1R15AR061737
Study First Received: September 18, 2012
Last Updated: December 12, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
biomechanics
outcomes
foot
orthotic device

Additional relevant MeSH terms:
Posterior Tibial Tendon Dysfunction
Foot Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 28, 2014