Effects of Plantar Sensory Training in Individuals With Hallux Valgus.
Investigation of the Effect of Plantar Sensory Training on Pain, Foot Posture, Functional Activities, Gait and Balance Parameters in Individuals With Hallux Valgus
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Typical duration 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
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 26, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2022
CompletedSeptember 28, 2023
September 1, 2023
2.1 years
March 26, 2022
September 27, 2023
Conditions
Keywords
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
EXPERIMENTALIn 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.
Control Group
ACTIVE COMPARATORRoutine 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.
Interventions
In addition to the routine treatment, plantar sensorial training will be added.
Eligibility Criteria
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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gul Yazicioglu, Prof
Hacettepe University
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