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RecruitingNCT06541119Updated Aug 12, 2024

Effect of Selective Strengthening of Peroneus Longus on Pain , Joint Alignment and Foot Function in Hallux Valgus

An interventional study of Selective Peroneus longus excercise and Conventional physical therapy programme in Hallux Valgus, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 2 years ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

02

Conditions studied

  • Hallux Valgus

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Keywords

  • Peroneus longus
  • Hallux valgus angle HVA
  • Kinovea software
  • Foot function index
  • Hallux pain
03

In context

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Selective peroneus longus strengthening exercise

    Group A will receive a weight bearing peroneus longus exercise with conventional physical therapy Programme

    Other: Selective Peroneus longus excercise

  • Active comparator
    Conventional physical therapy programme

    Group B will receive a program consisting of 3 commonly used exercises in Hallux valgus

    Other: Conventional physical therapy programme

Interventions

  • OtherSelective Peroneus longus excercise

    Weight bearing peroneus longus exercise

    Also known as: Band heel raises

  • OtherConventional physical therapy programme

    * Passive abduction of the Hallux with traction * short foot exercise * toe spread outs

06

What researchers measure

Primary outcomes

  1. Hallux valgus angle HVA

    Hallux valgus angle will be measures musing kinovea software

    Time frame: Baseline , 6 weeks (after study completion )

  2. Level of pain

    Will be measured using numerical pain rating scale Where 0 represents no pain and 10 represents worst pain imaginable

    Time frame: Baseline , 6 weeks after study completion

  3. 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).

    Time frame: Baseline , 6 weeks after study completion

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2024; primary completion for Nov 2024, 2 months later.

Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 2 months is below that.

Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2024
First posted
Aug 7, 2024
StartEst.
Sep 1, 2024
Primary completionEst.
Nov 1, 2024
CompletionEst.
Nov 15, 2024
Last update
Aug 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06541119
Lead sponsor
Cairo University
Responsible party
Asmaa Mohamed Kamel Hassan Alminisi (Senior physiotherapist, Cairo University) — Principal investigator
First posted
Aug 7, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Nov 1, 2024 (estimated)
Completion
Nov 15, 2024 (estimated)
Last update
Aug 12, 2024

Study contacts

Eman Abdel Moez, PhD
Contact
eman_ahmed@cu.edu.eg
+20 100 5220648

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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