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NCT Number: NCT07343752

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Blood Flow Restriction

Device

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

Primary outcomes

  1. American Orthopedic Foot and Ankle score (AOFAS)

    Time frame: baseline and 2 months

    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.

  2. Range of motion (ROM)

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

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

Secondary outcomes

  1. Muscle power

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

    Muscle power by dynamometer for: Tibialis anterior and Toe flexors

  2. Numerical Pain Rating Scale (NPRS).

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

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

  3. Patient satisfaction

    Time frame: last follow up, 2 months

    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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Does Adding Blood Flow Restriction Training to the Physical Therapy Program Improve Outcomes in Adolescents With Spasmodic Flatfoot Deformity?

Acronym: BFR SFFD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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