ClinicalTrials.gg
Not yet recruitingNCT07750106BFR-PTTDUpdated Aug 6, 2026

Blood Flow Restriction Training in Women With Posterior Tibial Tendon Dysfunction

An interventional study of Blood Flow Restriction Training and Conventional Physical Therapy Program in Posterior Tibial Tendon Dysfunction, sponsored by May University in Cairo. Not yet recruiting at 1 site in Egypt. Open to female participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by May University in Cairo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Posterior Tibial Tendon Dysfunction

Keywords

  • Posterior Tibial Tendon Dysfunction
  • Blood Flow Restriction
03

In context

Lead sponsor

May University in Cairo is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female 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
  • (BMI) between 18.5 and \<24.9 kg/m².
  • Willingness to participate and provide written .

Exclusion criteria

Exclusion Criteria:

  • Rigidity of the hindfoot.
  • Pain on palpation of the fibular muscles.
  • History of 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Blood Flow Restriction Group

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

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

  • Active comparator
    Conventional Physical Therapy Group

    Participants receive the same exercise program without blood flow restriction

    Behavioral: Conventional Physical Therapy Program

Interventions

  • DeviceBlood Flow Restriction Training

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

    Also known as: BFR

  • BehavioralConventional Physical Therapy Program

    Strengthening Exercises and ankle support

    Also known as: CPT

06

What researchers measure

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

07

Study locations

1 site
  • Faculty of Physical Therapy, May University in Cairo
    Cairo, Cairo Governorate, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Sep 2026, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2026
First posted
Aug 6, 2026
StartEst.
Aug 1, 2026
Primary completionEst.
Sep 1, 2026
CompletionEst.
Oct 1, 2026
Last update
Aug 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07750106
Lead sponsor
May University in Cairo
Responsible party
Hajar Mohammed Edris (Lecturer of physical therapy, Department of Basic Science, May University in Cairo) — Principal investigator
First posted
Aug 6, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Aug 6, 2026

Study contacts

Hajar M Edris, PhD
Contact
hajar.mohammed@muc.edu.eg
+201122243826

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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