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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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07343752
Acronym
BFR SFFD
Enrollment
40
Registered
2026-01-15
Start date
2025-08-18
Completion date
2026-12-31
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flat Foot; Spastic

Brief 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.

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
American Orthopedic Foot and Ankle score (AOFAS)baseline and 2 monthsAnkle-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.
Range of motion (ROM)baseline and at last follow up, 2 monthsAnkle range of motion of the sagittal plane (dorsiflexion and plantar flexion) and in the coronal plane (inversion and eversion), using a goniometer.

Secondary

MeasureTime frameDescription
Muscle powerbaseline and at last follow up, 2 monthsMuscle power by dynamometer for: Tibialis anterior and Toe flexors
Numerical Pain Rating Scale (NPRS).baseline and at last follow-up, 2 monthsPain level using NPRS, a scale from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable.
Patient satisfactionlast follow up, 2 monthsPatient 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026