Blood Flow Restriction Training in Women With Posterior Tibial Tendon Dysfunction (NCT07750106) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Blood Flow Restriction Training in Women With Posterior Tibial Tendon Dysfunction
Egypt54 participantsStarted 2026-08-01
Plain-language summary
Posterior tibial tendon dysfunction (PTTD) is a common musculoskeletal disorder characterized by pain, impaired foot function, and reduced dynamic stability. As one of the primary causes of adult-acquired flatfoot deformity, it can significantly affect walking ability, balance, and overall performance of daily activities. Although conventional rehabilitation typically emphasizes strengthening the posterior tibial tendon and surrounding muscles, these interventions may not fully address deficits in neuromuscular control and postural stability, highlighting the need for additional therapeutic approaches.
This randomized controlled trial aims to evaluate whether incorporating blood flow restriction (BFR) training into a rehabilitation program provides additional benefits for postmenopausal women with Stage I or flexible Stage II PTTD. A total of 54 eligible participants will be randomly allocated to either a BFR training group or a conventional exercise group. Clinical outcomes will be assessed before and after the intervention, including dynamic postural stability measured with the Biodex Balance System and active and passive ankle joint position sense assessed using the Biodex Isokinetic Dynamometer.
Who can participate
Age range
40 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female post-menopausal women aged 40-55 years.
* Clinically diagnosed with Stage I or flexible Stage II posterior tibial tendon dysfunction according to the Johnson and Strom classification modified by Myerson confirmed by an orthopedic physician.
* Symptoms persisting for ≥ 3 months.
* Pain intensity of ≥3/10 on the Visual Analogue Scale (VAS) during weight-bearing activities.
* Medically cleared to participate in blood flow restriction resistance training.
* Symptoms located at the medial ankle or foot.
* Pain on palpation of the posterior tibial tendon.
* A positive double and/or single heel-rise test.
* Able to walk independently without assistive devices
* Body Mass Index (BMI) between 18.5 and \<24.9 kg/m².
* Willingness to participate and provide written informed consent.
Exclusion Criteria:
* Rigidity of the hindfoot.
* Pain on palpation of the fibular muscles.
* History of corticosteroid injection in the tendon in a one-month period prior to the study onset.
* History of surgery to the hindfoot and/or ankle.
* History of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves) in either limb of the lower extremities.
* History of a fracture in either limb of the lower extremities requiring realignment.
* Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (i.e., sprains, fractures) resulting in interrupti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Stability Index (OSI)
Timeframe: Baseline and immediately after completion of the 4-week intervention
2
Anteroposterior Stability Index (APSI)
Timeframe: Baseline and immediately after completion of the 4-week intervention
3
Mediolateral Stability Index (MLSI)
Timeframe: Baseline and immediately after completion of the 4-week intervention
4
Limits of stability (LOS)
Timeframe: Baseline and immediately after completion of the 4-week intervention