NCT06541119

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 2, 2024

Last Update Submit

August 9, 2024

Conditions

Keywords

Peroneus longusHallux valgus angle HVAKinovea softwareFoot function indexHallux pain

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

EXPERIMENTAL

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

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

Other: Conventional physical therapy programme

Interventions

Weight bearing peroneus longus exercise

Also known as: Band heel raises
Selective peroneus longus strengthening exercise

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

Conventional physical therapy programme

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Cairo university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Central Study Contacts

Eman Abdel Moez, PhD

CONTACT

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

Locations