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Phase 2 N=39 Randomized Single-blind Treatment

Bracing and Strengthening for Posterior Tibial Tendon Dysfunction

Posterior Tibial Tendon Dysfunction

Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Foot Function Index(FFI) — 16.0; 12.7; 8.1; 8.3 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Bracing (Device); Strengthening exercises (Other); Stretching exercises (Other)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Ithaca College
Primary completion
Sep 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Foot Function Index(FFI)
16.0; 12.7; 8.1; 8.3; 9.8; 6.7
PRIMARY
Short Musculoskeletal Functional Assessment
22.2; 16.6; 13.0; 12.9; 14.5; 11.7
SECONDARY
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
-8.6; -8.8; -8.4; -8.2; -8.7; -8.8
SECONDARY
Foot Strength
0.70; 0.79; 0.77; 0.86; 0.78; 0.82

Summary

Posterior tibial tendon dysfunction (PTTD) is a problem with the tendon connecting one of the lower leg muscles to the foot bone. PTTD can cause pain, swelling, and a flattened foot and may require surgery if left untreated. Normal treatment for PTTD includes physical therapy exercise. In treating similar conditions in the lower leg, exercises that are active, like strengthening, seem to have better results than exercises that are passive, like stretching. This study will determine whether adding strengthening exercises to a normal PTTD treatment that includes wearing a brace and stretching is more beneficial than just wearing a brace and stretching.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Stage II PTTD disorder
  • Flexible flat foot deformity
  • Palpable tenderness of posterior tibial tendon
  • Swelling of the posterior tibial tendon sheath
  • Pain during single limb heel rise
  • Abnormal rear foot valgus
  • Abnormal fore foot abduction as compared to contralateral side

Exclusion Criteria

  • Unable to walk for more than 15 meters
  • Comorbidity within the foot
  • Loss of protective sensation of the foot, as indicated by Semmes-Weinstein monofilament test of 5.07
  • Inflammatory arthropathies
  • Score greater than 23 on Mini Mental Status exam
  • Arch index of less than 0.255
  • Inability to assume a subtalar neutral posture
  • PTTD in both feet
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00756457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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