Recruiting

Orthotic Devices

Sponsor:

State University of New York - Upstate Medical University

Code:

NCT01749657

Conditions

Posterior Tibial Tendon Dysfunction

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Arizona

Study Details

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.

Conditions

Posterior Tibial Tendon Dysfunction

Study ID

NCT01749657

Start date

Sep, 2012

Status verified date

Nov, 2014

Completion date

Aug, 2015

Anticipated

Primary completion date

Aug, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

experimental: Custom Device - standard and Shoe

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

experimental: Custom Articulated device and Shoe

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

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.

Interventions

Arizona

Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD).

Primary outcome measure

  • Foot Function Index - Revised [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Christopher G Neville, PhD, PT

315-464-9966nevillec@upstate.edu

Doreen Spencer

315-464-6881spenceDH@upstate.edu

Locations

Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Principal Investigator:

Christopher G Neville, PhD, PT

More Information

Sponsor

State University of New York - Upstate Medical University

Last update posted

Nov 20, 2014

Last verified

Nov, 2014

Keywords

  • biomechanics
  • outcomes
  • foot
  • orthotic device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York - Upstate Medical University on 2014-11-20.