Blood Flow Restriction Training in Women With Posterior Tibial Tendon Dysfunction

NCT07750106 | Not Yet Recruiting

• 1 other identifier: MUC
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posterior Tibial Tendon Dysfunction

Keywords

Posterior Tibial Tendon Dysfunction; Blood Flow Restriction

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and immediately after completion of the 4-week intervention

• Anteroposterior Stability Index (APSI)

  The Anteroposterior Stability Index (APSI) will be measured using the Biodex Balance System. APSI quantifies postural sway in the sagittal (anteroposterior) plane during static balance testing and is expressed in degrees. Lower APSI values indicate better balance control in the anteroposterior direction.

  Baseline and immediately after completion of the 4-week intervention

• Mediolateral Stability Index (MLSI)

  The Mediolateral Stability Index (MLSI) will be measured using the Biodex Balance System. MLSI quantifies postural sway in the frontal (mediolateral) plane during static balance testing and is expressed in degrees. Lower MLSI values indicate better balance control in the mediolateral direction.

  Baseline and immediately after completion of the 4-week intervention

• Limits of stability (LOS)

  Limits of Stability (LOS) will be assessed using the Biodex Balance System SD. LOS evaluates the participant's ability to voluntarily shift the center of gravity toward predefined targets while maintaining postural control. Performance is expressed as an overall percentage score (%), with higher values indicating better dynamic balance and postural control.

  Baseline and immediately after completion of the 4-week intervention

Secondary Outcomes (2)

• Active Ankle Joint Position Sense

  Baseline and immediately after completion of the 4-week intervention

• Passive Ankle Joint Position Sense

  Baseline and immediately after completion of the 4-week intervention

Study Arms (2)

Blood Flow Restriction Group

EXPERIMENTAL

Participants receive a conventional physical therapy program combined with blood flow restriction. Training

Device: Blood Flow Restriction Training; Behavioral: Conventional Physical Therapy Program

Conventional Physical Therapy Group

ACTIVE COMPARATOR

Participants receive the same exercise program without blood flow restriction

Behavioral: Conventional Physical Therapy Program

Interventions

Blood Flow Restriction Training DEVICE

Low-load Resistance exercise performed with a pneumatic cuff applied to the proximal lower extremities

Also known as: BFR

Blood Flow Restriction Group

Conventional Physical Therapy Program BEHAVIORAL

Strengthening Exercises and ankle support

Also known as: CPT

Blood Flow Restriction Group; Conventional Physical Therapy Group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: participants must self-identify as female and be postmenopausal
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• May University in Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, May University in Cairo

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Posterior Tibial Tendon Dysfunction

Interventions

Blood Flow Restriction Therapy; 2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Hajar M Edris, PhD

CONTACT

+201122243826; hajar.mohammed@muc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy, Department of Basic Science

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)