Observation on the Efficacy of Improving Ankle Dorsiflexion Limitation in Patients With Plantar Fasciitis
NCT Number: NCT06542211
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plantar Fasciitis
Interventions: BEHAVIORAL: Intervention plan for improving ankle dorsiflexion limitation group (experimental group)|BEHAVIORAL: Plantar fasciitis routine rehabilitation group
Sponsor: Peking University Third Hospital
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-20
Completion Date: 2025-03-02
Locations: Peking University Third Hospital, Beijing, Beijing, China

Summary:
This study aims to design a randomized controlled trial to treat plantar fasciitis by combining conventional rehabilitation with the improvement of ankle dorsiflexion function, and to explore its clinical efficacy by combining various evaluation indicators.

Compared with conventional plantar fasciitis, ankle dorsiflexion function rehabilitation training focuses more on the improvement of patients\&#39; foot and ankle function. Conventional PF rehabilitation training focuses on loosening the plantar fascia and gastrocnemius muscle, which can restore the elasticity of the plantar fascia and promote pain relief, but has limited improvement in ankle dorsiflexion function, resulting in patients\&#39; daily life such as walking, squatting, and going upstairs. Ankle dorsiflexion function rehabilitation training is an intervention directly targeting the function of the foot and ankle joint. By restoring the ankle dorsiflexion function of patients, it helps patients correct the force line in daily life movements, reduce the probability of sports injury risk, and improve sports performance and daily life satisfaction.

Conventional rehabilitation for plantar fasciitis mainly focuses on relaxing the plantar fascia, gastrocnemius muscle, and plantar flexor muscle strength and strengthening the small muscle group exercises of the plantar foot.

The experimental group directly intervened and conducted rehabilitation training for the limited ankle dorsiflexion function. It mainly includes subtalar joint loosening (increasing joint activity space), plantar flexor muscle group relaxation (releasing antagonist muscle tension), ankle dorsiflexor muscle strengthening (enhancing agonist muscle strength), and integrated exercises (integrating ankle dorsiflexion function into gait training).

This experiment lasted for a total of eight weeks, and patients were required to complete five home rehabilitation training sessions per week.

Primary Outcome Measures: Vicon 3D gait test, The subjects wore sports shorts, fully exposing the waist and the area below the mid-thigh. After the reflective markers were fixed, the subjects first familiarized themselves with the requirements and process of collecting movements according to the test procedures. The subjects stood in the center of the test room, with their feet shoulder-width apart and their upper limbs naturally placed on both sides of the body. They kept the subtalar joint in a neutral position and conducted three static tests to collect static data for defining the coordinate system of the bone segments. Afterwards, the subjects performed walking and jogging tests at the speed they felt most comfortable. The interval between the two tests was based on the patient not feeling tired. 5 valid data were collected for each action, and the average value of the 5 tests was used for analysis., 40min|Plantar fascia thickness measurement, The Japanese KONICA MINOLTA musculoskeletal ultrasound was used for testing, with a probe frequency of 3 to 18 Hz. Experienced clinicians were selected to perform the measurements. The patients were placed in a prone position with their ankle joints in a neutral position. The calcaneus and plantar fascia junction were measured. The doctor measured the plantar fascia thickness on the affected side of the patient, and the average value of three ultrasound measurement images was selected each time., 20min|Ankle dorsiflexion angle measurement, Ankle dorsiflexion angle in supine straight knee position and in lunge with bent knee position, 10min
Secondary Outcome Measures: Ankle and hindfoot function rating scale, American Orthopedic Foot Ankle Society (AOFAS) Ankle and Hindfoot Function Rating Scale: The scale is commonly used for rehabilitation assessment of foot pain and function, including 9 items: pain, function and autonomous activity, support, maximum walking distance (block), ground walking, abnormal gait, front and back activity (flexion and extension), hindfoot activity (inversion-extension), ankle-hindfoot stability (front and back and inversion-extension), foot force line. The total score of the scale is 100 points, no conversion is required, just add them up directly.

The grading standard is: excellent, 90-100 points; good, 75-89 points; acceptable, 50-74 points; poor, \<50 points., 10min|Visual Analogue Scale for Pain, The VAS pain visual analogue scale is a simple and clear method for pain statistics. It is one of the most commonly used scales for clinical pain statistics and is used to evaluate and monitor the degree of heel pain in patients before and after treatment. Draw a 10cm long horizontal line on the paper, with the starting end of the line at "0", representing no pain; the end of the line at "10", representing severe pain; the middle part of the line represents different degrees of pain; ask the patient to self-assess the heel pain when taking the first step in the morning and draw the corresponding position on the horizontal line., 20min|Plantar pressure test, The subjects walked barefoot on a footscan® pressure plate (RSscan, 2×0.4 m, 16,384 sensors) at a self-selected speed. The pressure plate was placed in the middle of a 30-m runway. Before the test, the subjects warmed up and became familiar with the barefoot walking procedure, and then took the test at a self-selected appropriate speed. If the heel did not touch the ground first during a test or the subject's walking speed differed from the average of their normal walking speed by more than 10%, the test was considered invalid and the subject was asked to retest. Five valid test data were collected from each foot for analysis.

The plantar pressure standardization method proposed by Keijsers et al. \[8\] was used for analysis: each foot was first scaled and rotated, and then the plantar pressure of each sensor was standardized with the plantar pressure of the whole foot., 20min