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 (BFR SFFD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Flat Foot; Spastic
• Intervention / Treatment: Device: blood flow restriction

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt
    • Recruiting
    • Assiut University Hospital, Physical Therapy Unit
    • Contact: Mariam Abdelazim Ibrahim, PhD; Phone Number: 00201001539399; Email: Mariam.A.ibrahim@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BFR; Adding BFR to traditional low-intensity training.	Device: blood flow restriction; The addition of BFR to low-load dynamic exercise training is effective for augmenting changes in both muscle strength and size.
No Intervention: control; traditional training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and 2 months
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.	baseline and at last follow up, 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle power	Muscle power by dynamometer for: Tibialis anterior and Toe flexors	baseline and at last follow up, 2 months
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.	baseline and at last follow-up, 2 months
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.	last follow up, 2 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Talipes; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Flatfoot; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: 04-2025-300682

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No