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

Primary Purpose

Posterior Tibial Tendon Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arizona
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Tibial Tendon Dysfunction focused on measuring biomechanics, outcomes, foot, orthotic device

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Upstate Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Off-the-shelf Device and shoe

Custom Device - standard and Shoe

Custom Articulated device and Shoe

Custom Extended Device and Shoe

Arm Description

subjects will wear an off-the-shelf orthotic device (AirLift PTTD Brace) and standard Edge shoe (Aetrex Co) for 12 weeks

subjects will wear a custom (standard) orthotic device (Arizona Co) and Edge shoes (Aetrex Co.) for 12 weeks.

subjects will wear a custom articulated device (Arizona Co) and Edge shoe (Aetrex Co)for 12 weeks

subjects will wear a custom extended foot plate orthotic device (Arizona Co) and Edge shoe (Aetrex Co) for 12 weeks.

Outcomes

Primary Outcome Measures

Foot Function Index - Revised
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
Assess the self-reported functional outcomes of patients with primarily foot and ankle pain.
Ankle Strength
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
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
Compare deep posterior compartment strength after 12 weeks across the 4 groups in the study

Full Information

First Posted
September 18, 2012
Last Updated
November 19, 2014
Sponsor
State University of New York - Upstate Medical University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT01749657
Brief Title
Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction
Official Title
Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York - Upstate Medical University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Tibial Tendon Dysfunction
Keywords
biomechanics, outcomes, foot, orthotic device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Off-the-shelf Device and shoe
Arm Type
Active Comparator
Arm Description
subjects will wear an off-the-shelf orthotic device (AirLift PTTD Brace) and standard Edge shoe (Aetrex Co) for 12 weeks
Arm Title
Custom Device - standard and Shoe
Arm Type
Experimental
Arm Description
subjects will wear a custom (standard) orthotic device (Arizona Co) and Edge shoes (Aetrex Co.) for 12 weeks.
Arm Title
Custom Articulated device and Shoe
Arm Type
Experimental
Arm Description
subjects will wear a custom articulated device (Arizona Co) and Edge shoe (Aetrex Co)for 12 weeks
Arm Title
Custom Extended Device and Shoe
Arm Type
Experimental
Arm Description
subjects will wear a custom extended foot plate orthotic device (Arizona Co) and Edge shoe (Aetrex Co) for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Arizona
Other Intervention Name(s)
Arizona Brace (3 different designs) versus AirLift PTTD Brace (DJ Orthopedics - AirCast Co)
Intervention Description
Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD).
Primary Outcome Measure Information:
Title
Foot Function Index - Revised
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Foot and Ankle Ability Measure
Description
Assess the self-reported functional outcomes of patients with primarily foot and ankle pain.
Time Frame
12 weeks
Title
Ankle Strength
Description
Compare strength changes over the 12 week intervention. Strength measures will include isometric and isokinetic testing using a Biodex System 3 strength testing system
Time Frame
12 weeks
Title
Hip Strength
Description
Compare strength changes over the 12 week intervention. Strength measures will include isometric and isokinetic testing using a Biodex System 3 strength testing system
Time Frame
12 weeks
Title
Deep Posterior Compartment Strength
Description
Compare deep posterior compartment strength after 12 weeks across the 4 groups in the study
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher G Neville, PhD, PT
Phone
315-464-9966
Email
nevillec@upstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Doreen Spencer
Phone
315-464-6881
Email
spenceDH@upstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher G Neville, PhD
Organizational Affiliation
Upstate Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher G Neville, PhD, PT
First Name & Middle Initial & Last Name & Degree
Frederick R Lemley, MD
First Name & Middle Initial & Last Name & Degree
Gary Brooks, PT, DrPH
First Name & Middle Initial & Last Name & Degree
Nathaniel Ordway, MS, PE

12. IPD Sharing Statement

Citations:
PubMed Identifier
22735283
Citation
Neville C, Lemley FR. Effect of ankle-foot orthotic devices on foot kinematics in Stage II posterior tibial tendon dysfunction. Foot Ankle Int. 2012 May;33(5):406-14. doi: 10.3113/FAI.2012.0406.
Results Reference
background

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

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