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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00756457 |
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.
Condition | Intervention | Phase |
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Posterior Tibial Tendon Dysfunction |
Device: Bracing Other: Strengthening exercises Other: Stretching exercises |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Bracing and Strengthening Exercises on Posterior Tibial Tendon Dysfunction |
Estimated Enrollment: | 50 |
Study Start Date: | July 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Participants in Group A will undergo bracing and perform stretching exercises.
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Device: 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.
Other: Stretching exercises
Participants will perform stretching exercises.
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B: Experimental
Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
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Device: 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.
Other: Strengthening exercises
Participants will perform strengthening exercises progressively longer each time for up to 3 sets of 30 repetitions twice daily by the third visit. Exercises will include bilateral heel raises, foot adduction/rear foot inversion with thera-tubing, and unilateral heel raises. Strengthening exercises will be preceded by a warm-up of the posterior tibialis muscle.
Participants will perform stretching exercises.
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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.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Ithaca College - Rochester Center | |
Rochester, New York, United States, 14620 |
Principal Investigator: | Jeff R. Houck, PhD, PT | Ithaca College - Rochester Center |
Responsible Party: | Ithaca College-Rochester Center ( Dr. Jeff R. Houck, Associate Professor ) |
Study ID Numbers: | R15 AR054507 |
Study First Received: | September 19, 2008 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00756457 History of Changes |
Health Authority: | United States: Federal Government |
PTTD Tendinopathy Tendon Injuries Muscular Diseases Foot Diseases |
Tendinopathy Tendon Injuries Muscular Diseases |
Musculoskeletal Diseases Posterior Tibial Tendon Dysfunction Foot Diseases |
Musculoskeletal Diseases Posterior Tibial Tendon Dysfunction Foot Diseases |