Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-01-02 @ 9:54 AM
Study NCT ID:
NCT00756457
Status:
COMPLETED
Last Update Posted:
2014-07-02
First Post:
2008-09-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bracing and Strengthening for Posterior Tibial Tendon Dysfunction
Sponsor:
Ithaca College
Organization:
Study Overview
Official Title:
The Effect of Bracing and Strengthening Exercises on Posterior Tibial Tendon Dysfunction
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R15AR054507 | NIH | None | https://reporter.nih.gov/quic… | View |