Bracing and Strengthening for Posterior Tibial Tendon Dysfunction

NCT ID: NCT00756457

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-09-30

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.

Conditions

Posterior Tibial Tendon Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Treatment Group

Participants in Group A will undergo bracing and perform stretching exercises.

Group Type: ACTIVE_COMPARATOR

Bracing

Intervention Type: DEVICE

Participants will wear a brace that includes ankle stirrup support and medial longitudinal arch support. The brace will be worn during weight-bearing tasks throughout the 12-week study.

Stretching exercises

Intervention Type: OTHER

Subjects were provided with written descriptions and pictures demonstrating 2 range-of-motion exercises which included a wall calf stretch, and a supine ankle active range-of-motion exercise. Subjects were instructed to perform 3 sets of the stretching exercises, 2 times a day, similar to the intervention group. Each stretching exercise was performed twice and held for 30 seconds.

Passive Treatment Group

Participants in Group B will undergo bracing and perform stretching and strengthening exercises.

Group Type: EXPERIMENTAL

Bracing

Intervention Type: DEVICE

Participants will wear a brace that includes ankle stirrup support and medial longitudinal arch support. The brace will be worn during weight-bearing tasks throughout the 12-week study.

Strengthening exercises

Intervention Type: OTHER

Participants performed strengthening exercises progressively longer each time for up to 3 sets of 30 repetitions twice daily by the third visit. Exercises included bilateral heel raises, foot adduction/rear foot inversion with thera-tubing, and unilateral heel raises. Participants increased resistance by using thera-bands with higher levels of resistance over the 12 week period. The amount of resistance was progressed according to patient tolerance at each visit. Strengthening exercises were preceded by the control stretching exercises which constituted a "warm up."

Stretching exercises

Intervention Type: OTHER

Subjects were provided with written descriptions and pictures demonstrating 2 range-of-motion exercises which included a wall calf stretch, and a supine ankle active range-of-motion exercise. Subjects were instructed to perform 3 sets of the stretching exercises, 2 times a day, similar to the intervention group. Each stretching exercise was performed twice and held for 30 seconds.

Interventions

Bracing

Participants will wear a brace that includes ankle stirrup support and medial longitudinal arch support. The brace will be worn during weight-bearing tasks throughout the 12-week study.

Intervention Type: DEVICE

Strengthening exercises

Participants performed strengthening exercises progressively longer each time for up to 3 sets of 30 repetitions twice daily by the third visit. Exercises included bilateral heel raises, foot adduction/rear foot inversion with thera-tubing, and unilateral heel raises. Participants increased resistance by using thera-bands with higher levels of resistance over the 12 week period. The amount of resistance was progressed according to patient tolerance at each visit. Strengthening exercises were preceded by the control stretching exercises which constituted a "warm up."

Intervention Type: OTHER

Stretching exercises

Subjects were provided with written descriptions and pictures demonstrating 2 range-of-motion exercises which included a wall calf stretch, and a supine ankle active range-of-motion exercise. Subjects were instructed to perform 3 sets of the stretching exercises, 2 times a day, similar to the intervention group. Each stretching exercise was performed twice and held for 30 seconds.

Intervention Type: OTHER

Other Intervention Names

Air Lift Brace

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Ithaca College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff R. Houck, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Ithaca College - Rochester Center

Locations

Ithaca College - Rochester Center

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25857939 (View on PubMed)

Other Identifiers

R15AR054507

Identifier Type: NIH

Identifier Source: secondary_id

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R15AR054507

Identifier Type: NIH

Identifier Source: org_study_id

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