- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05462002
Intrinsic Foot Muscle Morphology and Function in Runners With and Without Plantar Fasciitis
Study Overview
Status
Conditions
Detailed Description
this is a case-control study, using ultrasound imaging (USG) to examine the differences in muscle thickness (MT) and cross-sectional area (CSA) of Abductor Hallucis (AbH), flexor hallucis brevis (FHB), flexor digitorum brevis (FDB), and quadratus plantae (QP), and postural control in runners with and without plantar fasciitis. All participants were recruited through recruitment flyers and word of mouth from local running community. The dependent variables included navicular height using navicular drop test, foot posture using the 6-item Foot Posture Index (FPI-6). The actual status of symptoms was evaluated by visual analog scale (VAS) pain at the first steps in the morning, VAS pain at worst of the day, the Foot Function Index Revised short form (FFI-R S), and the Foot and Ankle Ability Measure (FAAM).
The postural control was assessed by three 10-seconds eyes opened trials and three 10-seconds eyes closed trials single-leg stance recorded on an instrumented force platform . (AMTI. Watertown, MA) at 50 Hz. Center of pressure velocity (cm/s) was calculated for each condition using Balance Clinic software (AMTI. Watertown, MA). In addition, percent modulation was calculated using equation 1 to provide an estimate of a participant's reliance on visual information for the postural control of intrinsic foot muscles.
Equation 1 is as followed.
% modulation= (eyes open velocity-eyes closed velocity)/(eyes open velocity)
Larger negative values represent a greater impairment to postural control when vision is removed and suggest a greater reliance on visual information.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Sha Tin, Hong Kong
- Recruiting
- CUHK-ORT Sports Injury Research Laboratory
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Contact:
- On Yue LAU, Phd candidate
- Phone Number: (852) 64604033
- Email: fannielauoy@link.cuhk.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- distance runners who run more than 20km per week for at least 2 years. Runners who were between 18 and 60 years of age with symptoms of chronic plantar fasciitis: if they reported tenderness on palpation of the medial calcaneal tuberosity, thickness of plantar fascia >4.0mm at insertion with USG, and exhibited one of the following complaints: 1. plantar heel pain > 1 month; 2 pain on the first step in the morning or after prolonged sitting; 3. pain on prolonged standing; 4 pain when running.
Exclusion Criteria:
- Those who had undergone surgery to the plantar fascia, or had local injection within the last 3 months, or had any coexisting painful musculoskeletal condition of the lower limb, or any neurological or systematic disease were excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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plantar fasciitis group
Distance runners with plantar fasciitis
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asymptomatic control group
Distance runners without plantar fasciitis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) pain at first steps in the morning
Time Frame: baseline
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measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
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baseline
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Visual Analog Scale (VAS) worst pain of the day
Time Frame: baseline
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measuring 100 mm in length marked from 0 (absence of pain) to 100 mm (worst imaginable pain)
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baseline
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Foot and Ankle Ability Measure (FAAM)
Time Frame: baseline
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Higher scores represent higher levels of function, with 100% representing no dysfunction.
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baseline
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Muscle thickness (MT) of Abductor Hallucis (AbH), Flexor Hallucis Brevis (FHB), Flexor Digitorum Brevis (FDB), Quadratus Plantae (QP)
Time Frame: baseline
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ultrasound measurement
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baseline
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Cross sectional area (CSA) of Abductor Hallucis (AbH), Flexor Hallucis Brevis (FHB), Flexor Digitorum Brevis (FDB), Quadratus Plantae (QP)
Time Frame: baseline
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ultrasound measurement
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baseline
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postural control
Time Frame: baseline
|
three 10-seconds eyes opened trials and three 10-seconds eyes closed trials single-leg stance recorded on an instrumented force platform. percent modulation was calculated using equation 1 to provide an estimate of a participant's reliance on visual information for the postural control of intrinsic foot muscles. Equation 1 is as followed. % modulation= (eyes open velocity-eyes closed velocity)/(eyes open velocity) Larger negative values represent a greater impairment to postural control when vision is removed and suggest a greater reliance on visual information. |
baseline
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Foot Function Index revised short form (FFI-RS)
Time Frame: baseline
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grade 1 corresponds to no pain and 4 corresponds to worst pain imaginable.
The numerical 5 is not used as a score but is used to indicate that the subscale question is not applicable for the participant.
Higher scores represent higher levels of pain, stiffness, difficulty, activity limitation, and psychosocial aspect
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot posture index (FPI)
Time Frame: Baseline
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Pronated postures are given a positive value, the higher the value the more pronated.
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Baseline
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Navicular drop
Time Frame: Baseline
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Supinated foot (<5mm); Neutral foot (5-9mm); pronated foot (>9mm)
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: On Yue Lau, PhD candidate, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PF_IFM_Training
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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