The Effect of Insoles in Plantar Fasciitis
Insoles
The Effect of Insoles on Muscle Activation and Gait Parameters in Plantar Fasciitis
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
It aims to investigate the effect of two personalized insoles made of different materials designed to reduce pain in individuals with plantar fasciitis on muscle activation and gait parameters at 3-month follow-up.
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 Sep 2024
Typical duration for not_applicable
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 19, 2024
CompletedFirst Posted
Study publicly available on registry
August 20, 2024
CompletedStudy Start
First participant enrolled
September 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2026
ExpectedAugust 23, 2024
August 1, 2024
4 months
August 19, 2024
August 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Electromyography
Muscle activation data will be recorded with BIOSIGNALSPLUX Researcher Kit brand EMG device. EMG is a frequently used method that evaluates muscle activation as a lens. In EMG measurements, signals are classified non-invasively using surface electrodes (20) The electrodes are planned according to the Gluteus Maximus, Gluteus Medius, Rectus Femoris, Biceps Femoris, Gastrocnemius Medialis and Lateralis, Soleus, Tibialis Anterior muscles.
Change from Baseline of treatment at 3 months
Secondary Outcomes (4)
Pedobarographic Analysis
Change from Baseline of treatment at 3 months
Foot Function Index (FFI)
Change from Baseline of treatment at 3 months
Satisfaction Evaluation
Change from Baseline of treatment at 3 months
Sensory Evaluation
Change from Baseline of treatment at 3 months
Study Arms (2)
EVA INSOLES
ACTIVE COMPARATOR3D INSOLES
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Being between the ages of 18-65,
- Being diagnosed with plantar fasciitis,
- Being prescribed custom insoles,
- Having complaints for at least 3 months,
- Heel pain complaint is at the plantar medial calcaneal tubercle,
- Pain complaint is most evident in the first steps taken in the morning or in the steps after resting,
- Having a Roles and Maudsley score of 3 or 4 in the initial evaluation
You may not qualify if:
- Having a body mass index greater than 30 kg/m2,
- Having any cardiopulmonary, dermatological, neurological or orthopedic problems other than plantar fasciitis,
- Having a history of foot or ankle surgery,
- Using an assistive device (walker, canadiens, etc.)
- Not using appropriate shoes,
- Having cognitive, mental and/or psychological problems
- Being pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
August 19, 2024
First Posted
August 20, 2024
Study Start
September 16, 2024
Primary Completion
January 6, 2025
Study Completion (Estimated)
July 21, 2026
Last Updated
August 23, 2024
Record last verified: 2024-08