Effect of Selective Strengthening of Peroneus Longus on Pain , Joint Alignment and Foot Function in Hallux Valgus
1 other identifier
interventional
60
1 country
1
Brief 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 conventional physical therapy programme in cases of hallux valgus patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2024
CompletedAugust 12, 2024
August 1, 2024
2 months
August 2, 2024
August 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Hallux valgus angle HVA
Hallux valgus angle will be measures musing kinovea software
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
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).
Baseline , 6 weeks after study completion
Study Arms (2)
Selective peroneus longus strengthening exercise
EXPERIMENTALGroup A will receive a weight bearing peroneus longus exercise with conventional physical therapy Programme
Conventional physical therapy programme
ACTIVE COMPARATORGroup B will receive a program consisting of 3 commonly used exercises in Hallux valgus
Interventions
Weight bearing peroneus longus exercise
* Passive abduction of the Hallux with traction * short foot exercise * toe spread outs
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo university
Giza, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Sixty mild to moderate Hallux valgus patients will be evaluated for eligibility ; participants will be randomized in 1:1 ratio using computer generated block randomization , followed by concealed allocation by opening quantity numbered sealed envelopes , a card inside will reveal the group assignment as either group A, or group B.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior physiotherapist
Study Record Dates
First Submitted
August 2, 2024
First Posted
August 7, 2024
Study Start
September 1, 2024
Primary Completion
November 1, 2024
Study Completion
November 15, 2024
Last Updated
August 12, 2024
Record last verified: 2024-08