ClinicalTrials.gg
RecruitingNCT07343752BFR SFFDUpdated Jan 15, 2026

To Evaluate the Efficiency and Results of Adding BFR to the Physical Therapy Program fo Managing Adolescents Presented With Spasmotic Flatfoot Deformities Compared to the Standard Physical Therapy Program Without BFR

An interventional study of blood flow restriction in Flat Foot; Spastic, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Aug 2025, registered Dec 2025).
  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Study summary

The goal of this randomized clinical trial is to evaluate the efficiency and results of adding blood flow restriction (BFR) training to the physical therapy program for managing adolescents presented with spasmotic flatfoot deformities compared to the Standard physical therapy program without blood flow restriction.

02

Conditions studied

  • Flat Foot; Spastic
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
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

  • Adolescents presented with idiopathic, rigid, spasmodic flatfeet.
  • Age should be younger than 18 years old. 3- Patients who did not respond to initial medical treatment for three weeks.

Exclusion criteria

Exclusion Criteria:

  • generalised tarsal arthritis
  • neurological disorder.
  • secondary rigid flatfoot deformity
  • patients who did not complete the follow up or evaluation protocol
  • Patients who will refuse to participate
05

Study design

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

Study arms

  • Experimental
    BFR

    Adding BFR to traditional low-intensity training.

    Device: blood flow restriction

  • No intervention
    control

    traditional training

Interventions

  • Deviceblood flow restriction

    The addition of BFR to low-load dynamic exercise training is effective for augmenting changes in both muscle strength and size.

06

What researchers measure

Primary outcomes

  1. American Orthopedic Foot and Ankle score (AOFAS)

    Ankle-Hindfoot Scale: a standard method of reporting the clinical and functional status of the ankle and foot. The systems incorporate both subjective and objective factors into numerical scales to describe function, alignment, and pain. A score of 100 points is possible in a patient with no pain, full range of sagittal and hindfoot motion, no ankle or hindfoot instability, good alignment, ability to walk more than six blocks, ability to ambulate on any walking surface, no discernible limp, no limitation of daily or recreational activities, and no assistive devices needed for ambulation. Fifty points were assigned to function, 40 to pain, and 10 to alignment.

    Time frame: baseline and 2 months

  2. Range of motion (ROM)

    Ankle range of motion of the sagittal plane (dorsiflexion and plantar flexion) and in the coronal plane (inversion and eversion), using a goniometer.

    Time frame: baseline and at last follow up, 2 months

Secondary outcomes

  1. Muscle power

    Muscle power by dynamometer for: Tibialis anterior and Toe flexors

    Time frame: baseline and at last follow up, 2 months

  2. Numerical Pain Rating Scale (NPRS).

    Pain level using NPRS, a scale from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable.

    Time frame: baseline and at last follow-up, 2 months

  3. Patient satisfaction

    Patient satisfaction: patient satisfaction was initially collected by a simple yes or no question and if they were willing to go through the same protocol again and if they were satisfied with the results followed by detailed measurements using the 0 to 10 scale reported by Park et al., where 0 is extremely unsatisfied, and 10 is extremely satisfied.

    Time frame: last follow up, 2 months

07

Study locations

1 of 1 sites recruiting
  • Assiut University Hospital, Physical Therapy Unit
    Asyut, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07343752
Lead sponsor
Assiut University
Responsible party
Mariam ibrahim (Physical tharapist, Assiut University) — Principal investigator
First posted
Jan 15, 2026
Start date
Aug 18, 2025
Primary completion
Aug 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 15, 2026

Oversight

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

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