Flat Foot; SpasticBFR SFFDNCT07343752
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
A study testing blood flow restriction in people with Flat Foot; Spastic, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Flat Foot; Spastic
- What is being tested?
- blood flow restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital, Physical Therapy Unit
Asyut
Mariam Abdelazim Ibrahim, PhD, 00201001539399, Mariam.A.ibrahim@med.aun.edu.eg
About this study
Official title: 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.
- Conditions
- Flat Foot; Spastic
- Being tested
- blood flow restriction
- Medical subject headings
- Flatfoot, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood flow restrictionDevice
The addition of BFR to low-load dynamic exercise training is effective for augmenting changes in both muscle strength and size.
| Study group | Role | What they receive |
|---|---|---|
| BFR | Experimental | Adding BFR to traditional low-intensity training. Receives: Device: blood flow restriction |
| control | No intervention | traditional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline and at last follow up, 2 months
Secondary outcomes (3)
Muscle power
Muscle power by dynamometer for: Tibialis anterior and Toe flexors
Measured: 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.
Measured: 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.
Measured: last follow up, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start18 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat Foot; SpasticStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343752
- Sponsor's protocol ID
- 04-2025-300682
- Acronym
- BFR SFFD
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding Blood Flow Restriction Training to the Physical Therapy Program Improve Outcomes in Adolescents With Spasmodic Flatfoot Deformity?
- ClinicalTrials.gov ID
- NCT07343752
- Acronym / sponsor ID
- BFR SFFD / 04-2025-300682
- Conditions
- Flat Foot; Spastic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR | Experimental | Device: blood flow restrictionAdding BFR to traditional low-intensity training. |
| control | No intervention | –traditional training |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood flow restrictionThe addition of BFR to low-load dynamic exercise training is effective for augmenting changes in both muscle strength and size. | Device | BFR |
Primary outcome
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.
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.
3 secondary outcomes
Muscle power
Time frame: baseline and at last follow up, 2 months
Numerical Pain Rating Scale (NPRS).
Time frame: baseline and at last follow-up, 2 months
Patient satisfaction
Time frame: last follow up, 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assiut University Hospital, Physical Therapy Unit
Asyut, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood flow restriction in people with Flat Foot; Spastic, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopedic Foot and Ankle score (AOFAS) (time frame: baseline and 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.