- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06541119
Effect of Selective Strengthening of Peroneus Longus on Pain , Joint Alignment and Foot Function in Hallux Valgus
August 9, 2024 updated by: Asmaa Mohamed Kamel Hassan Alminisi, Cairo University
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eman Abdel Moez, PhD
- Phone Number: +20 100 5220648
- Email: eman_ahmed@cu.edu.eg
Study Locations
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-
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Giza, Egypt
- Recruiting
- Cairo University
-
Contact:
- Eman Abdel Moez, PhD
- Phone Number: +20 100 5220648
- Email: eman_ahmed@cu.edu.eg
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Selective peroneus longus strengthening exercise
Group A will receive a weight bearing peroneus longus exercise with conventional physical therapy Programme
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Weight bearing peroneus longus exercise
Other Names:
|
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Active Comparator: Conventional physical therapy programme
Group B will receive a program consisting of 3 commonly used exercises in Hallux valgus
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hallux valgus angle HVA
Time Frame: Baseline , 6 weeks (after study completion )
|
Hallux valgus angle will be measures musing kinovea software
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Baseline , 6 weeks (after study completion )
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|
Level of pain
Time Frame: Baseline , 6 weeks after study completion
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Will be measured using numerical pain rating scale Where 0 represents no pain and 10 represents worst pain imaginable
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Baseline , 6 weeks after study completion
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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).
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Baseline , 6 weeks after study completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
November 15, 2024
Study Registration Dates
First Submitted
August 2, 2024
First Submitted That Met QC Criteria
August 2, 2024
First Posted (Actual)
August 7, 2024
Study Record Updates
Last Update Posted (Actual)
August 12, 2024
Last Update Submitted That Met QC Criteria
August 9, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/005050
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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