Hallux ValgusNCT06541119
Effect of Selective Strengthening of Peroneus Longus on Pain , Joint Alignment and Foot Function in Hallux Valgus
A study testing Selective Peroneus longus excercise and Conventional physical therapy programme in people with Hallux Valgus, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose of this study is to measure Change in Hallux valgus angle (HVA )as measured by kinovea software Change in pain as measured by numerical pain rating scale (NPRS) Change in function as measured by Foot function index (FFI )Egyptian version With the peroneus longus strengthening exercise versus the use of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Selective Peroneus longus excercise and Conventional physical therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 15 Nov 2024
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients must be diagnosed as having mild to moderate Hallux valgus (with Hallux valgus angle between 15-40 degrees)
- patients aging between 18-60 .
- patients must report pain and limited function .
- patients must report that they are not undergoing physiotherapy , not using orthosis , dynamic splinting exercises for Hallux valgus
Who cannot join
- Patients diagnosed with systematic diseases such as rheumatoid arthritis .
- Cognitive or mental illness.
- Hallux rigidus or limitus .
- History of surgery to foot of Hallux .
- Previous use of foot orthosis .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Giza
Eman Abdel Moez, PhD, +20 100 5220648, eman_ahmed@cu.edu.eg
About this study
Official title: Effect of Selective Strengthening of Peroneus Longus Muscles on Pain Joint Alignment and Foot Function in Hallux Valgus
Purpose of this study is to measure Change in Hallux valgus angle (HVA )as measured by kinovea software Change in pain as measured by numerical pain rating scale (NPRS) Change in function as measured by Foot function index (FFI )Egyptian version With the peroneus longus strengthening exercise versus the use of conventional physical therapy programme in cases of hallux valgus patients
- Conditions
- Hallux Valgus
- Being tested
- Selective Peroneus longus excercise, Conventional physical therapy programme
- Keywords
- Peroneus longus, Hallux valgus angle HVA, Kinovea software, Foot function index, Hallux pain
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Peroneus longus excerciseOther
Also called Band heel raises
Weight bearing peroneus longus exercise
Conventional physical therapy programmeOther
- Passive abduction of the Hallux with traction
- short foot exercise
- toe spread outs
| Study group | Role | What they receive |
|---|---|---|
| Selective peroneus longus strengthening exercise | Experimental | Group A will receive a weight bearing peroneus longus exercise with conventional physical therapy Programme Receives: Other: Selective Peroneus longus excercise |
| Conventional physical therapy programme | Active comparator | Group B will receive a program consisting of 3 commonly used exercises in Hallux valgus Receives: Other: Conventional physical therapy programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallux valgus angle HVA
Hallux valgus angle will be measures musing kinovea software
Measured: Baseline , 6 weeks (after study completion )
Level of pain
Will be measured using numerical pain rating scale Where 0 represents no pain and 10 represents worst pain imaginable
Measured: Baseline , 6 weeks after study completion
Foot function
Will be measured using Foot Function Index FFI Egyptian version Which is divided into 3 sub categories Pain 0 no pain , 10 worst pain Disability 0 least 10 worst Activity limitation 0 no limitation , 10 worst limitation For the total score, the minimum score is 0% (no pain or difficulty), and maximum score is 100% (worst pain and extreme difficulty requiring assistance).
Measured: Baseline , 6 weeks after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Kamel Hassan Alminisi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541119
- Sponsor's protocol ID
- 012/005050
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selective Strengthening of Peroneus Longus Muscles on Pain Joint Alignment and Foot Function in Hallux Valgus
- ClinicalTrials.gov ID
- NCT06541119
- Acronym / sponsor ID
- 012/005050
- Conditions
- Hallux Valgus
- Keywords
- Peroneus longus, Hallux valgus angle HVA, Kinovea software, Foot function index, Hallux pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 7 Aug 2024 (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.
Purpose of this study is to measure Change in Hallux valgus angle (HVA )as measured by kinovea software Change in pain as measured by numerical pain rating scale (NPRS) Change in function as measured by Foot function index (FFI )Egyptian version With the peroneus longus strengthening exercise versus the use of conventional physical therapy programme in cases of hallux valgus patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective peroneus longus strengthening exercise | Experimental | Other: Selective Peroneus longus excerciseGroup A will receive a weight bearing peroneus longus exercise with conventional physical therapy Programme |
| Conventional physical therapy programme | Active comparator | Other: Conventional physical therapy programmeGroup B will receive a program consisting of 3 commonly used exercises in Hallux valgus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All patients must be diagnosed as having mild to moderate Hallux valgus (with Hallux valgus angle between 15-40 degrees)
- patients aging between 18-60 .
- patients must report pain and limited function .
- patients must report that they are not undergoing physiotherapy , not using orthosis , dynamic splinting exercises for Hallux valgus
Key exclusion criteria (5 listed)
- Patients diagnosed with systematic diseases such as rheumatoid arthritis .
- Cognitive or mental illness.
- Hallux rigidus or limitus .
- History of surgery to foot of Hallux .
- Previous use of foot orthosis .
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 |
|---|---|---|
| Selective Peroneus longus excerciseAlso: Band heel raisesWeight bearing peroneus longus exercise | Other | Selective peroneus longus strengthening exercise |
| Conventional physical therapy programme* Passive abduction of the Hallux with traction * short foot exercise * toe spread outs | Other | Conventional physical therapy programme |
Primary outcome
Hallux valgus angle HVA
Time frame: Baseline , 6 weeks (after study completion )
Hallux valgus angle will be measures musing kinovea software
Level of pain
Time frame: Baseline , 6 weeks after study completion
Will be measured using numerical pain rating scale Where 0 represents no pain and 10 represents worst pain imaginable
Foot function
Time frame: Baseline , 6 weeks after study completion
Will be measured using Foot Function Index FFI Egyptian version Which is divided into 3 sub categories Pain 0 no pain , 10 worst pain Disability 0 least 10 worst Activity limitation 0 no limitation , 10 worst limitation For the total score, the minimum score is 0% (no pain or difficulty), and maximum score is 100% (worst pain and extreme difficulty requiring assistance).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Peroneus longus excercise and Conventional physical therapy programme in people with Hallux Valgus, 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 4 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 12 Aug 2024. 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 Eman Abdel Moez, PhD (+20 100 5220648, eman_ahmed@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hallux valgus angle HVA (time frame: Baseline , 6 weeks (after study completion )). The study lists 3 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 12 Aug 2024.