Haglund DeformityNCT05905952
Postural Stability and Ankle Mobility in Haglund Syndrome
An observational study of Haglund Deformity, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to find out the impact of Haglund syndrome on ankle plantarflexion and dorsiflexion ROM, dynamic postural stability and fall risk. Read more about this study
- Who is it for?
- Ages 25 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- Haglund Deformity
- What is being tested?
- balance and ROM assessment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients with Haglund syndrome
Who may be able to join
- For patient group:
- Patient referred from orthopedic surgeon with diagnoses as Haglund syndrome according to the following signs and symptoms
- Calcaneal prominence diagnosed on lateral weight bearing radiograph with bony prominence superior to parallel pitch lines or posterior calcaneal angle greater than 75 degrees
- Pain medially at insertion of tendo-achilles
- Palpation of hard, bony prominence
- Pain upon rising out of bed
Show all 12Show fewer
- Both unilateral and bilateral cases, and in consideration of dealing with bilateral cases the tested limb will be the most painful limb.
- Age of 25-56 years
- Both males and females.
- BMI of (18.5 to 24.9)
- For control group:
- Healthy volunteers of matched age, sex and body mass index without any musculoskeletal complaints of the lower limbs and will be included in the control group in this study .
Who cannot join
- Musculoskeletal disorders except Haglund syndrome
- cognitive disorder, visual impairment that affected their daily living and any further medical condition that would prohibit them from participating safely in the chosen balance measures
- sensory loss at foot or ankle and with a systemic inflammatory disease, such as diabetes mellitus, peripheral neuropathy, rheumatoid arthritis and ankylosing spondylitis, who had undergone corticosteroid injections or physical therapy in the last three months
- Patients with vestibular or neurological disorders
- Any other cause of posterior heel pain.
Trial locations and contacts
1 site in 1 country.
enas F youssif, prof contact
Egypt1 site, 1 recruiting
- Recruiting
Deraya University
Minya, 05673
nassif M mousa, bachelor, 01273152233, nassif.magdy.mousa@gmail.com
mohamed A abdelmegeed, PHD, 01223631604
About this study
Official title: Evaluation of Postural Stability and Ankle Mobility in Haglund Syndrome
The purpose of the study is to find out the impact of Haglund syndrome on ankle plantarflexion and dorsiflexion ROM, dynamic postural stability and fall risk.
Read the detailed description
This study will be delimited to:
- Total sample size is fifty participants, twenty five patient of symptomatic Haglund syndrome of both gender and twenty five healthy volunteers of matched age, sex and body mass index without any musculoskeletal complaints of the lower limbs.
- Biodex balance system will be used to determine postural stability.
- Ankle plantarflexion and dorsiflexion range of motion will be measured using an Electrogoniometer.
- Age of the patients 25-56
- BMI of (18.5 to 24.9)
Participants:
Fifty volunteers from both genders will participate in the study. They will be assigned from outpatient clinic of Faculty of Physical Therapy, Deraya University. They will be interviewed and divided to twenty five patient of Haglund syndrome as (patient group) after being diagnosed and referred by orthopedic surgeon and twenty five Healthy volunteers as (control group) based on the following inclusion and exclusion criteria:
- Conditions
- Haglund Deformity
- Being tested
- balance and ROM assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance and ROM assessmentDiagnostic test
assessment of postural stability and ankle range of motion
| Study group | Role | What they receive |
|---|---|---|
| patient group | to twenty five patient of Haglund syndrome as (patient group) after being diagnosed and referred by orthopedic surgeon and twenty Receives: Diagnostic Test: balance and ROM assessment | |
| control group | twenty five Healthy volunteers as (control group) based on the following inclusion and exclusion criteria Receives: Diagnostic Test: balance and ROM assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural stability test report
a measurement of the antero-posterior, medio-lateral and overall stability and range of motion
Measured: 1 day
ankle range of motion test
measuring of ankle planter and dorsiflexion range of motion with digital goniometer
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start12 Mar 2023
- Primary completion30 Jul 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haglund DeformityStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nassif Magdy Mousa, Cairo University
- Investigators
- enas F youssif, prof, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905952
- Sponsor's protocol ID
- P.T.REC/ 012/004497
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publication in peer-reviewed journals
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postural Stability and Ankle Mobility in Haglund Syndrome
- ClinicalTrials.gov ID
- NCT05905952
- Acronym / sponsor ID
- P.T.REC/ 012/004497
- Conditions
- Haglund Deformity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 15 Jun 2023 (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 purpose of the study is to find out the impact of Haglund syndrome on ankle plantarflexion and dorsiflexion ROM, dynamic postural stability and fall risk.
Detailed description
This study will be delimited to:
- Total sample size is fifty participants, twenty five patient of symptomatic Haglund syndrome of both gender and twenty five healthy volunteers of matched age, sex and body mass index without any musculoskeletal complaints of the lower limbs.
- Biodex balance system will be used to determine postural stability.
- Ankle plantarflexion and dorsiflexion range of motion will be measured using an Electrogoniometer.
- Age of the patients 25-56
- BMI of (18.5 to 24.9)
Participants:
Fifty volunteers from both genders will participate in the study. They will be assigned from outpatient clinic of Faculty of Physical Therapy, Deraya University. They will be interviewed and divided to twenty five patient of Haglund syndrome as (patient group) after being diagnosed and referred by orthopedic surgeon and twenty five Healthy volunteers as (control group) based on the following inclusion and exclusion criteria:
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | – | Diagnostic Test: balance and ROM assessmentto twenty five patient of Haglund syndrome as (patient group) after being diagnosed and referred by orthopedic surgeon and twenty |
| control group | – | Diagnostic Test: balance and ROM assessmenttwenty five Healthy volunteers as (control group) based on the following inclusion and exclusion criteria |
Who may qualify
- Ages
- 25 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients with Haglund syndrome
Key inclusion criteria (12 listed)
- For patient group:
- Healthy volunteers of matched age, sex and body mass index without any musculoskeletal complaints of the lower limbs and will be included in the control group in this study .
Key exclusion criteria (5 listed)
- Musculoskeletal disorders except Haglund syndrome
- cognitive disorder, visual impairment that affected their daily living and any further medical condition that would prohibit them from participating safely in the chosen balance measures
- sensory loss at foot or ankle and with a systemic inflammatory disease, such as diabetes mellitus, peripheral neuropathy, rheumatoid arthritis and ankylosing spondylitis, who had undergone corticosteroid injections or physical therapy in the last three months
- Patients with vestibular or neurological disorders
- Any other cause of posterior heel pain.
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 |
|---|---|---|
| balance and ROM assessmentassessment of postural stability and ankle range of motion | Diagnostic test | control group, patient group |
Primary outcome
postural stability test report
Time frame: 1 day
a measurement of the antero-posterior, medio-lateral and overall stability and range of motion
ankle range of motion test
Time frame: 1 day
measuring of ankle planter and dorsiflexion range of motion with digital goniometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Yes. publication in peer-reviewed journals
Related trials for Haglund Deformity
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
Active, not recruiting
Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders
Tendon Tear, Tendinopathy
RecruitingObservational study
Zadek Osteotomy for Treatment of Haglund's Syndrome
Haglund's Disease
RecruitingObservational study
Embo Registry; National Registry for Artery Embolization
Chronic Pain, Osteoarthritis, Knee
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. This study is not recruiting at the moment.
enas F youssif, prof contact
enas F youssif, prof principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haglund Deformity, run by Cairo 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 12 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nassif M mousa, Bachelor (01273152233 ext. el minia, nassif.magdy.moussa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postural stability test report (time frame: 1 day). 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 Jun 2023.