Treatment Effects on Gait in Hammertoe Patients
ConditionHammertoe
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Texas Rio Grande Valley
About this trial
This study looks at how hammertoe deformities affect foot pressure distribution and whether proper treatment can improve quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed distal symmetric sensory neuropathy.
MTPJ hyperextension deformity.
Claw or hammer toe deformity in toes.
Disqualifiers
Non-hammertoe foot deformities affecting metatarsal head pressure.
Limited joint mobility, lower-limb amputation, or Charcot neuro-osteoarthropathy.
Peripheral vascular disease
Non-diabetic neuropathies
Trial design
Design model
Parallel
Treatments tested in this trial
Conservative
Other interventionPatients with hammertoe deformities will undergo conservative treatments, including wearing proper shoes, insoles, and custom orthotics.
Surgical
Procedure/SurgeryPatients with hammertoe deformities will undergo surgical treatments.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Conservative TreatmentExperimental treatment 1 intervention
Group B: Surgical TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
In-shoe Peak Plantar Pressure
In-shoe peak plantar pressure data will be recorded as patients walk with a pressure-measuring sensor placed inside their shoes. The unit will be Kilopascal (kPa).
Time frame
Pre-intervention, Post-intervention (3 months)Secondary outcomes
1
Quality of Life Questionnaire
Medical Outcomes Study 36-item Short Form questionnaires (SF-36) will be used to assess the quality of life. The SF-36 form has four subsections: pain, distance, walking speed, and stair climbing. Each subsection score ranges from 0 to 100 (where 0 is the worst, and 100 is the best health status).
Time frame
Pre-intervention, Post-intervention (3 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov