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

NCT07343752 | Recruiting

• 1 other identifier: 04-2025-300682
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Flat Foot; Spastic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Muscle power

  baseline and at last follow up, 2 months

• Numerical Pain Rating Scale (NPRS).

  baseline and at last follow-up, 2 months

• Patient satisfaction

  last follow up, 2 months

Study Arms (2)

BFR

EXPERIMENTAL

Adding BFR to traditional low-intensity training.

Device: blood flow restriction

control

NO INTERVENTION

traditional training

Interventions

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.

BFR

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital, Physical Therapy Unit

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Flatfoot; Muscle Spasticity

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical tharapist

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 15, 2026
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-12

Locations

EG (1)