Blood Flow Restriction Training in Women With Posterior Tibial Tendon Dysfunction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorMay University in Cairo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood Flow Restriction Training

    Device

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

  • Conventional Physical Therapy Program

    Behavioral

    Strengthening Exercises and ankle support

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Blood Flow Restriction GroupExperimental treatment 2 interventions
Group B: Conventional Physical Therapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and immediately after completion of the 4-week intervention
2

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.

Time frame
Baseline and immediately after completion of the 4-week intervention
3

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.

Time frame
Baseline and immediately after completion of the 4-week intervention
4

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.

Time frame
Baseline and immediately after completion of the 4-week intervention

Secondary outcomes

1

Active Ankle Joint Position Sense

Active ankle joint position sense will be assessed using the Biodex Isokinetic Dynamometer during an active joint reposition test in the sagittal plane. The outcome is expressed as the absolute angular repositioning error in degrees (°). Lower values indicate better proprioceptive accuracy.

Time frame
Baseline and immediately after completion of the 4-week intervention
2

Passive Ankle Joint Position Sense

Passive ankle joint position sense will be assessed using the Biodex Isokinetic Dynamometer during a passive joint repositioning test in the sagittal plane. The outcome is expressed as the absolute angular repositioning error in degrees (°). Lower values indicate better proprioceptive accuracy.

Time frame
Baseline and immediately after completion of the 4-week intervention

Other outcomes

Sponsors and contacts

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