NCT05344755

Brief Summary

Hallux valgus is a forefoot deformity with a high prevalence, which can progress to lateral deviation of the big toe, medial deviation of the first metatarsal, and subluxation of the first metatarsophalangeal joint in the future. It has been reported in studies that changes in the load distribution of the foot in hallux valgus patients, hyperkeratosis, especially first-line pain, and sensory receptors on the sole of the foot may result in the effect of sensory receptors on the sole of the foot, and thus the balance may be negatively affected, poor postural stability and an increase in the risk of falling. It is thought that increased sensitivity to the senses coming from the feet with sensory training can improve the balance and reduce the risk of falling as a result of better perception of foot orientation and position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

March 26, 2022

Last Update Submit

September 27, 2023

Conditions

Keywords

hallux valguspainsensory trainingplantar sensory

Outcome Measures

Primary Outcomes (1)

  • Change in Foot-Related pain assessment

    Visual Analogue Scale will be used to evaluate the pain severity of individuals. Participants will be asked to mark their pain at rest and activity on a horizontal line of 100 millimeters, with 100 indicating maximum pain and 0 indicating no pain.

    change from baseline pain severity at 6 weeks

Secondary Outcomes (5)

  • Change in Light touch sensation

    change from baseline light touch sensation at 6 weeks

  • Change in foot function

    change from baseline foot function at 6 weeks

  • Change in lower extremity functional level

    change from baseline Lower extremity functional level at 6 weeks

  • Change in gait parameters

    change from baseline temporo-spatial gait parameters at 6 weeks

  • Change in balance

    change from baseline postural sway and limits of stability at 6 weeks

Study Arms (2)

Plantar Sensorial Training

EXPERIMENTAL

In addition to hallux valgus mobilization, active thumb abduction, strengthening of the muscles around the feet, hallux valgus taping and hallux valgus night splint, sensory training (using deep plantar massage, brushing, dipping techniques) will be performed.

Other: Plantar Sensorial Training

Control Group

ACTIVE COMPARATOR

Routine hallux valgus physiotherapy approaches such as: hallux valgus mobilization, active thumb abduction, strengthening of the muscles around the feet, hallux valgus taping and hallux valgus night splint.

Other: Control Group

Interventions

In addition to the routine treatment, plantar sensorial training will be added.

Plantar Sensorial Training

Routine physiotherapy management of the Hallux valgus

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with mild or moderate hallux valgus;
  • Volunteer to participate in the study

You may not qualify if:

  • Having pathologies that may cause sensory problems such as diabetes, multiple sclerosis, myelomeningocele, severe disc herniation,
  • Having an orthopedic, rheumatological or neurological disease other than hallux valgus that will prevent participation in the exercise program
  • Having previous foot surgery,
  • Having a cooperation problem at a level that cannot understand and apply the exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hallux ValgusPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Gul Yazicioglu, Prof

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 25, 2022

Study Start

October 1, 2020

Primary Completion

October 27, 2022

Study Completion

November 15, 2022

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations