Plantar FasciitisNCT06542211
Observation on the Efficacy of Improving Ankle Dorsiflexion Limitation in Patients With Plantar Fasciitis
A study testing Intervention plan for improving ankle dorsiflexion limitation group (experimental group) and Plantar fasciitis routine rehabilitation group in people with Plantar Fasciitis, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Intervention plan for improving ankle dorsiflexion limitation group (experimental group) and Plantar fasciitis routine rehabilitation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 2 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range: 30-60 years old; disease course \> 3 months; pain cannot be relieved by conservative treatment such as rest, oral nonsteroidal drugs, and physical therapy; VAS score is less than 6 points.
- According to the clinical practice guidelines of the International Classification of Functioning, Disability and Health: Heel Pain/Plantar Fasciitis: 2014 Revision [16], patients meet the clinical diagnostic criteria for PF, mainly including pain on the medial side of the plantar, heel pain caused by recent weight-bearing activities, pain on palpation of the proximal attachment of the plantar fascia, and positive Windlass test;
- Supine straight knee ankle dorsiflexion angle \<10°; lunge knee flexion \<40° [50, 51]; left and right foot dorsiflexion difference does not exceed 1°.
- BMI between 18.5-23.9 (Chinese standard)
Who cannot join
- (1) Those who have received local injections of steroids in the past 3 months; (2) Those with other foot, ankle and lower leg diseases: history of surgery, fracture, trauma, plantar skin ulcers, rheumatism or rheumatoid arthritis, etc.; (3) Those with serious medical diseases: such as blood diseases, coagulopathy, severe cardiovascular and cerebrovascular dysfunction, tumor diseases, etc.
- Those with peripheral neuropathy (idiopathic, diabetic, nutritional); L5/S1 neural foramen impingement or lumbar spinal stenosis (5) Congenital structural flat feet, equinus deformity or other foot and ankle joint diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Hongshi Huang, 13910093298, huanghs@bjmu.edu.cn
About this study
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\' 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\' 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.
Read more
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.
Read the detailed description
Plantar fasciitis (PF) is a common musculoskeletal injury characterized by inflammation and degeneration at the origin of the fascia and causing heel pain. The disease affects individuals of different ages and activity levels and is the main cause of plantar pain and ankle dysfunction in patients, accounting for 15% of all foot diseases. A previous study showed that PF is more common in middle-aged and elderly people and those who love sports. One in 10 people has their daily quality of life seriously affected by PF. In clinical work, it was found that there was a large difference in the degree of ankle function of PF patients at the time of consultation. The clinical symptoms of plantar fasciitis are mainly heel pain when landing in the morning or after a long rest. The symptoms are aggravated after standing or walking for a long time, and sometimes patients will show a pain-reducing gait. The diagnosis is mainly based on the patient\'s symptoms and signs. There are often local tenderness points when palpating along the plantar fascia and the medial tubercle of the calcaneus. The patient\'s ankle dorsiflexion range of motion may be limited. Ultrasound examination shows increased thickness of the plantar fascia. The patient may also show bone spurs growing into the fascia on X-rays . The cause of plantar fasciitis is still unclear. Its risk factors include age, obesity, foot deformity, limited ankle dorsiflexion, decreased foot proprioception, long-term weight-bearing and walking activities . These factors are interrelated and interact with each other, and the abnormal biomechanical mechanism of the foot is the key to the internal connection between these factors . Poor foot-ankle force line and biomechanics will increase abnormal stress on the plantar fascia during joint movement, leading to micro-tears of the fascia, and then thickening and tightening of the plantar fascia, resulting in inflammation. At present, the intervention treatment methods for plantar fasciitis are divided into two categories: surgery and conservative treatment. Most patients are treated with conservative treatment, which mainly includes insole adjustment, physical therapy and weight loss. Physical therapy programs generally include stretching the plantar fascia and calf muscles, muscle strength training, taping, the use of orthotics and night splints, etc.. Currently, the short-term effect is acceptable, but the long-term effect is poor, and it is easy to relapse, which affects the overall motor function and sports performance.
People have higher and higher requirements for health. In addition to paying attention to local pain relief, patients with plantar fasciitis also have higher demands for improving sports performance. Conventional physical therapy methods can effectively relieve the temporary pain of patients with plantar fasciitis, but the recovery of patients\' motor function is still poor. Only relieving short-term pain symptoms can no longer fully meet people\'s daily life and sports needs. For the long-term rehabilitation of plantar fasciitis, the correction of poor foot biomechanics and the improvement of foot and ankle function are the key to preventing and improving physical function and improving sports performance. Ankle dorsiflexion dysfunction will reduce various sports performances and increase the compensation of other joint functions in the body, thereby increasing the risk and probability of sports injuries. Relevant studies have shown that limited ankle dorsiflexion is one of the causes of plantar fasciitis. A study showed that 211 out of 254 patients had limited ankle dorsiflexion . Individuals with insufficient ankle dorsiflexion during walking may roll their feet forward by dropping the talus and flattening the medial longitudinal arch. The flattening of the arch may stretch the plantar fascia, which may lead to inflammation of the plantar fascia over time . However, the current treatment methods for plantar fasciitis have failed to systematically improve the limited ankle dorsiflexion function of patients, and limited ankle joint function may directly affect the long-term treatment effect of plantar fasciitis.
In summary, since the correction of poor foot force line and the recovery of ankle dorsiflexion function play an important role in the long-term treatment effect of plantar fasciitis, this study aims to design a randomized controlled trial to treat plantar fasciitis in combination with conventional rehabilitation and improvement of limited ankle dorsiflexion function, and to explore its clinical efficacy in combination with various evaluation indicators.
- Conditions
- Plantar Fasciitis
- Being tested
- Intervention plan for improving ankle dorsiflexion limitation group (experimental group), Plantar fasciitis routine rehabilitation group
- Keywords
- ankle dorisflexion, plantar fasciitis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention plan for improving ankle dorsiflexion limitation group (experimental group)Behavioural
The experimental group received intervention and rehabilitation training directly for the limited ankle dorsiflexion function, which mainly included subtalar joint loosening (increasing the joint activity space), plantar flexor muscle group relaxation (releasing the tension of antagonist muscles), ankle dorsiflexor muscle strengthening (enhancing the strength of agonist muscles), and integrated exercises (integrating ankle dorsiflexion function into gait training).
Plantar fasciitis routine rehabilitation groupBehavioural
The experimental group received intervention and rehabilitation training directly for the limited ankle dorsiflexion function, which mainly included subtalar joint loosening (increasing the joint activity space), plantar flexor muscle group relaxation (releasing the tension of antagonist muscles), ankle dorsiflexor muscle strengthening (enhancing the strength of agonist muscles), and integrated exercises (integrating ankle dorsiflexion function into gait training).
| Study group | Role | What they receive |
|---|---|---|
| Plantar Fasciitis Test Group | Experimental | The experimental group received intervention and rehabilitation training directly for the limited ankle dorsiflexion function, which mainly included subtalar joint loosening (increasing the joint activity space), plantar flexor muscle group relaxation (releasing the tension of antagonist muscles), ankle dorsiflexor muscle strengthening (enhancing the strength of agonist muscles), and integrated exercises (integrating ankle dorsiflexion function into gait training). Receives: Behavioral: Intervention plan for improving ankle dorsiflexion limitation group (experimental group) |
| Plantar fasciitis conventional rehabilitation group | Active comparator | Conventional rehabilitation for plantar fasciitis mainly focuses on relaxing the plantar fascia, gastrocnemius and plantar flexor muscles and strengthening the small muscle groups of the plantar foot. Receives: Behavioral: Plantar fasciitis routine rehabilitation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 20min
Ankle dorsiflexion angle measurement
Ankle dorsiflexion angle in supine straight knee position and in lunge with bent knee position
Measured: 10min
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 20min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start20 May 2024
- Primary completion2 Mar 2025 (estimated)
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542211
- Sponsor's protocol ID
- M2023360
- Status last verified
- May 2024
- First submitted
- 4 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation on the Efficacy of Improving Ankle Dorsiflexion Limitation in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06542211
- Acronym / sponsor ID
- M2023360
- Conditions
- Plantar Fasciitis
- Keywords
- ankle dorisflexion, plantar fasciitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 2 Mar 2025 (estimated)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\' 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\' 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.
Detailed description
Plantar fasciitis (PF) is a common musculoskeletal injury characterized by inflammation and degeneration at the origin of the fascia and causing heel pain. The disease affects individuals of different ages and activity levels and is the main cause of plantar pain and ankle dysfunction in patients, accounting for 15% of all foot diseases. A previous study showed that PF is more common in middle-aged and elderly people and those who love sports. One in 10 people has their daily quality of life seriously affected by PF. In clinical work, it was found that there was a large difference in the degree of ankle function of PF patients at the time of consultation. The clinical symptoms of plantar fasciitis are mainly heel pain when landing in the morning or after a long rest. The symptoms are aggravated after standing or walking for a long time, and sometimes patients will show a pain-reducing gait. The diagnosis is mainly based on the patient\'s symptoms and signs. There are often local tenderness points when palpating along the plantar fascia and the medial tubercle of the calcaneus. The patient\'s ankle dorsiflexion range of motion may be limited. Ultrasound examination shows increased thickness of the plantar fascia. The patient may also show bone spurs growing into the fascia on X-rays . The cause of plantar fasciitis is still unclear. Its risk factors include age, obesity, foot deformity, limited ankle dorsiflexion, decreased foot proprioception, long-term weight-bearing and walking activities . These factors are interrelated and interact with each other, and the abnormal biomechanical mechanism of the foot is the key to the internal connection between these factors . Poor foot-ankle force line and biomechanics will increase abnormal stress on the plantar fascia during joint movement, leading to micro-tears of the fascia, and then thickening and tightening of the plantar fascia, resulting in inflammation. At present, the intervention treatment methods for plantar fasciitis are divided into two categories: surgery and conservative treatment. Most patients are treated with conservative treatment, which mainly includes insole adjustment, physical therapy and weight loss. Physical therapy programs generally include stretching the plantar fascia and calf muscles, muscle strength training, taping, the use of orthotics and night splints, etc.. Currently, the short-term effect is acceptable, but the long-term effect is poor, and it is easy to relapse, which affects the overall motor function and sports performance.
People have higher and higher requirements for health. In addition to paying attention to local pain relief, patients with plantar fasciitis also have higher demands for improving sports performance. Conventional physical therapy methods can effectively relieve the temporary pain of patients with plantar fasciitis, but the recovery of patients\' motor function is still poor. Only relieving short-term pain symptoms can no longer fully meet people\'s daily life and sports needs. For the long-term rehabilitation of plantar fasciitis, the correction of poor foot biomechanics and the improvement of foot and ankle function are the key to preventing and improving physical function and improving sports performance. Ankle dorsiflexion dysfunction will reduce various sports performances and increase the compensation of other joint functions in the body, thereby increasing the risk and probability of sports injuries. Relevant studies have shown that limited ankle dorsiflexion is one of the causes of plantar fasciitis. A study showed that 211 out of 254 patients had limited ankle dorsiflexion . Individuals with insufficient ankle dorsiflexion during walking may roll their feet forward by dropping the talus and flattening the medial longitudinal arch. The flattening of the arch may stretch the plantar fascia, which may lead to inflammation of the plantar fascia over time . However, the current treatment methods for plantar fasciitis have failed to systematically improve the limited ankle dorsiflexion function of patients, and limited ankle joint function may directly affect the long-term treatment effect of plantar fasciitis.
In summary, since the correction of poor foot force line and the recovery of ankle dorsiflexion function play an important role in the long-term treatment effect of plantar fasciitis, this study aims to design a randomized controlled trial to treat plantar fasciitis in combination with conventional rehabilitation and improvement of limited ankle dorsiflexion function, and to explore its clinical efficacy in combination with various evaluation indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plantar Fasciitis Test Group | Experimental | Behavioral: Intervention plan for improving ankle dorsiflexion limitation group (experimental group)The experimental group received intervention and rehabilitation training directly for the limited ankle dorsiflexion function, which mainly included subtalar joint loosening (increasing the joint activity space), plantar flexor muscle group relaxation (releasing the tension of antagonist muscles), ankle dorsiflexor muscle strengthening (enhancing the strength of agonist muscles), and integrated exercises (integrating ankle dorsiflexion function into gait training). |
| Plantar fasciitis conventional rehabilitation group | Active comparator | Behavioral: Plantar fasciitis routine rehabilitation groupConventional rehabilitation for plantar fasciitis mainly focuses on relaxing the plantar fascia, gastrocnemius and plantar flexor muscles and strengthening the small muscle groups of the plantar foot. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range: 30-60 years old; disease course \> 3 months; pain cannot be relieved by conservative treatment such as rest, oral nonsteroidal drugs, and physical therapy; VAS score is less than 6 points.
- According to the clinical practice guidelines of the International Classification of Functioning, Disability and Health: Heel Pain/Plantar Fasciitis: 2014 Revision [16], patients meet the clinical diagnostic criteria for PF, mainly including pain on the medial side of the plantar, heel pain caused by recent weight-bearing activities, pain on palpation of the proximal attachment of the plantar fascia, and positive Windlass test;
- Supine straight knee ankle dorsiflexion angle \<10°; lunge knee flexion \<40° [50, 51]; left and right foot dorsiflexion difference does not exceed 1°.
- BMI between 18.5-23.9 (Chinese standard)
Key exclusion criteria (2 listed)
- (1) Those who have received local injections of steroids in the past 3 months; (2) Those with other foot, ankle and lower leg diseases: history of surgery, fracture, trauma, plantar skin ulcers, rheumatism or rheumatoid arthritis, etc.; (3) Those with serious medical diseases: such as blood diseases, coagulopathy, severe cardiovascular and cerebrovascular dysfunction, tumor diseases, etc.
- Those with peripheral neuropathy (idiopathic, diabetic, nutritional); L5/S1 neural foramen impingement or lumbar spinal stenosis (5) Congenital structural flat feet, equinus deformity or other foot and ankle joint diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention plan for improving ankle dorsiflexion limitation group (experimental group)The experimental group received intervention and rehabilitation training directly for the limited ankle dorsiflexion function, which mainly included subtalar joint loosening (increasing the joint activity space), plantar flexor muscle group relaxation (releasing the tension of antagonist muscles), ankle dorsiflexor muscle strengthening (enhancing the strength of agonist muscles), and integrated exercises (integrating ankle dorsiflexion function into gait training). | Behavioural | Plantar Fasciitis Test Group |
| Plantar fasciitis routine rehabilitation groupThe experimental group received intervention and rehabilitation training directly for the limited ankle dorsiflexion function, which mainly included subtalar joint loosening (increasing the joint activity space), plantar flexor muscle group relaxation (releasing the tension of antagonist muscles), ankle dorsiflexor muscle strengthening (enhancing the strength of agonist muscles), and integrated exercises (integrating ankle dorsiflexion function into gait training). | Behavioural | Plantar fasciitis conventional rehabilitation group |
Primary outcome
Vicon 3D gait test
Time frame: 40min
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.
Plantar fascia thickness measurement
Time frame: 20min
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.
Ankle dorsiflexion angle measurement
Time frame: 10min
Ankle dorsiflexion angle in supine straight knee position and in lunge with bent knee position
3 secondary outcomes
Ankle and hindfoot function rating scale
Time frame: 10min
Visual Analogue Scale for Pain
Time frame: 20min
Plantar pressure test
Time frame: 20min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention plan for improving ankle dorsiflexion limitation group (experimental group) and Plantar fasciitis routine rehabilitation group in people with Plantar Fasciitis, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongshi Huang (13910093298, huanghs@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vicon 3D gait test (time frame: 40min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.