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Blood Flow Restriction Training in Women With Posterior Tibial Tendon Dysfunction (BFR-PTTD)

1 août 2026 mis à jour par: Hajar Mohammed Edris, May University in Cairo

Effects of Blood Flow Restriction Training on Dynamic Postural Stability and Proprioception in Post-Menopausal Women With Posterior Tibial Tendon Dysfunction: A Randomized Controlled 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

54

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Egypte
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypte
        • Faculty of Physical Therapy, May University in Cairo
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Blood Flow Restriction Group
Participants receive a conventional physical therapy program combined with blood flow restriction. Training
Dispositif: Blood Flow Restriction Training
Low-load Resistance exercise performed with a pneumatic cuff applied to the proximal lower extremities
Autres noms:
  • RFB
Comportemental: Conventional Physical Therapy Program
Strengthening Exercises and ankle support
Autres noms:
  • CPT
Comparateur actif: Conventional Physical Therapy Group
Participants receive the same exercise program without blood flow restriction
Comportemental: Conventional Physical Therapy Program
Strengthening Exercises and ankle support
Autres noms:
  • CPT

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Stability Index (OSI)
Délai: Baseline and immediately after completion of the 4-week intervention
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)
Délai: Baseline and immediately after completion of the 4-week intervention
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)
Délai: Baseline and immediately after completion of the 4-week intervention
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)
Délai: Baseline and immediately after completion of the 4-week intervention
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Active Ankle Joint Position Sense
Délai: Baseline and immediately after completion of the 4-week intervention
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.
Baseline and immediately after completion of the 4-week intervention
Passive Ankle Joint Position Sense
Délai: Baseline and immediately after completion of the 4-week intervention
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.
Baseline and immediately after completion of the 4-week intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

May University in Cairo

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 septembre 2026

Achèvement de l'étude (Estimé)

1 octobre 2026

Dates d'inscription aux études

Première soumission

28 juillet 2026

Première soumission répondant aux critères de contrôle qualité

1 août 2026

Première publication (Réel)

6 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MUC

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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