Clinical trial NCT00756457: Bracing and Strengthening for Posterior Tibial Tendon Dysfunction
Official title: The Effect of Bracing and Strengthening Exercises on Posterior Tibial Tendon Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posterior Tibial Tendon Dysfunction
Keywords: PTTD
Tendinopathy
Tendon Injuries
Muscular Diseases
Foot Diseases
Lead sponsor: Ithaca College
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2008-09-22
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Posterior tibial tendon dysfunction (PTTD) involves inflammation, overstretching, or both of the posterial tibial tendon, which connects the tibialis posterior muscle to the bones in the foot. PTTD can cause pain in the inner ankle and development of a flat foot. Without treatment, correction of PTTD may require surgery. Standard interventions that may prevent the need for surgery include orthotic devices, bracing, and physical therapy, among other possibilities. Within physical therapy, foot exercises can be either active-as in the case of strengthening exercises-or passive-as in the case of stretching exercises. Evidence from clinical treatment of similar conditions suggests that active exercises are more effective than passive exercises in leading to recovery. This study will determine whether adding strengthening exercises to a normal intervention of bracing and stretching is more effective in improving a range of symptoms in stage II PTTD patients than using only bracing and stretching exercises.

Participants with Stage II PTTD will be recruited and placed in one of two groups for the duration of the 12-week study. The first group will undergo regular bracing and perform stretching exercises. The second group will undergo regular bracing and perform stretching and strengthening exercises. Braces, worn during weight-bearing tasks throughout the study, will include ankle stirrup support and medial longitudinal arch support. Strengthening exercises, which will be preceded by a warm-up of the posterior tibialis muscle, will include bilateral heel raises, foot adduction and rear foot inversion with thera-tubing, and unilateral heel raises. Frequency of exercise and number of repetitions will increase over the course of the study until participants are performing 3 sets of 30 repetitions 2 times per day. Assessments, which will occur at study entry, after 6 weeks, and after 12 weeks, will include foot range of motion, length of the posterior tibial muscle, and self-assessments of function.

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

Primary outcomes:
measure: Foot Function Index(FFI)
timeFrame: Measured at Weeks 1, 6, and 12
measure: Short Musculoskeletal Functional Assessment
timeFrame: Measured at Weeks 1, 6, and 12
Secondary outcomes:
measure: Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
timeFrame: Measured at Weeks 1,6 and 12
measure: Foot Strength
timeFrame: Measured at Weeks 1, 6, and 12
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Ithaca College - Rochester Center
state: New York
Study officials:
affiliation: Ithaca College - Rochester Center
name: Jeff R. Houck, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Houck J, Neville C, Tome J, Flemister A. Randomized Controlled Trial Comparing Orthosis Augmented by Either Stretching or Stretching and Strengthening for Stage II Tibialis Posterior Tendon Dysfunction. Foot Ankle Int. 2015 Sep;36(9):1006-16. doi: 10.1177/1071100715579906. Epub 2015 Apr 9.