Blood Flow Restriction Training in Women With Posterior Tibial Tendon Dysfunction

N/ANot Yet RecruitingNCT07750106

May University in Cairo54 enrolled

Overview

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.

Posterior tibial tendon dysfunction (PTTD) is a progressive musculoskeletal disorder that affects the integrity and function of the posterior tibial tendon, leading to pain, impaired foot support, decreased postural stability, and functional limitations. As one of the most common causes of adult-acquired flatfoot deformity, PTTD can substantially interfere with walking, balance, and other daily activities. The condition is particularly prevalent among middle-aged and older women. In postmenopausal women, age-related declines in muscle strength, tendon quality, and neuromuscular function may further compromise lower-limb stability and physical performance. Blood flow restriction (BFR) training has emerged as a promising rehabilitation technique in which low-load resistance exercise is performed while a pneumatic cuff applies controlled pressure to the proximal portion of the limb. By partially restricting blood flow during exercise, this approach enables individuals to achieve training adaptations that are typically associated with higher exercise intensities while using considerably lower loads. Although BFR has shown encouraging results in the rehabilitation of various musculoskeletal conditions, its effectiveness in individuals with PTTD, particularly postmenopausal women, has not been adequately investigated. This randomized controlled trial aims to compare the effects of a rehabilitation program incorporating blood flow restriction training with those of a conventional rehabilitation exercise program in postmenopausal women with Stage I or flexible Stage II posterior tibial tendon dysfunction. Eligible participants will be randomly assigned to one of the two intervention groups. Outcome measures will be assessed at baseline and after completion of 4 weeks. The primary outcome will be dynamic postural stability, measured using the Biodex Balance System. Secondary outcomes will include active and passive ankle joint position sense assessed using the Biodex Isokinetic Dynamometer The findings of this study are expected to expand the current evidence regarding the use of blood flow restriction training in the rehabilitation of posterior tibial tendon dysfunction. They may also help guide future evidence-based rehabilitation strategies aimed at improving functional outcomes and postural stability in postmenopausal women with this condition.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 interruption of desired physical activity. * Hip joint or knee joint replacement. * Patients who were possibly at risk of adverse reactions of blood flow restriction (i.e., poor circulatory system, obesity, diabetes, arterial calcification, sickle cell trait, severe hypertension, or renal failure). * Any neurological conditions that affect proprioception, such as polyneuropathy, multiple sclerosis, and sensory ataxia. * Vestibular deficits and vision problems.

Outcomes

Primary Outcomes

Overall Stability Index (OSI)

The Overall Stability Index (OSI) will be measured using the Biodex Balance System. The OSI quantifies the overall variance of platform displacement from level during static balance testing and is expressed in degrees. Lower OSI values indicate better postural stability.