Chronic Ankle Instability,CACAINCT06251414
Study on the Effect of Exercise Intervention Combined With Physical Therapy on Chronic Ankle Instability Symptoms
A study testing Exercise Intervention, Instrument-Assisted Soft Tissue Mobilization and Tuinal in people with Chronic Ankle Instability,CA, run by Yang Liu at 1 site in China.
Trial summary
Purpose; Through experimental observation of exercise intervention (blood flow restriction training combined with low load ankle muscle strength training and balance training) combined with instrument tool therapy (Instrument Soft Tissue Release Technique, IASTM), the intervention effect on ankle function, strength… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Chronic Ankle Instability,CA
- What is being tested?
- Exercise Intervention, Instrument-Assisted Soft Tissue Mobilization and Tuinal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 30 Dec 2023
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-35 years old
- Course of illness: Suffering from chronic ankle instability symptoms that last for at least 3 months
- Symptoms: Ankle instability, frequent ankle sprains, discomfort during walking or exercise
- Functional screening: Two or more tests tested positive for ankle joint function screening before the experiment
- Structural examination: No joint structural lesions or congenital ankle deformities,
- Medical history: Have not undergone ankle surgery or have external injuries
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- Health status: No serious heart, lung, nervous system or other systemic diseases
- Exercise level: Able to complete the exercise intervention and evaluation tasks specified in the experiment
- Agree to participate in the study: Has limited exercise ability and is unable to complete the research task
Who cannot join
- Under 18 years old or over 35 years old
- Acute ankle injury or no joint injury
- No ankle instability or unwillingness to cooperate with research requirements
- Failed ankle function screening
- Structural lesions or congenital ankle deformities present in the ankle joint
- Have undergone ankle surgery or have obvious injuries or wounds
Show all 9Show fewer
- Serious heart, lung, nervous system or other systemic diseases
- Due to limited athletic ability, unable to complete research tasks
- Disagree to participate in the study, or inability to understand and comply with the research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effect of Blood Flow Restriction Training Combined With IASTAM on Symptoms in Patients With Chronic Ankle Instability
Purpose; Through experimental observation of exercise intervention (blood flow restriction training combined with low load ankle muscle strength training and balance training) combined with instrument tool therapy (Instrument Soft Tissue Release Technique, IASTM), the intervention effect on ankle function, strength, and joint range of motion of sports dance athletes with ankle instability was observed.
Method; 45 subjects with unstable, restricted or uncomfortable ankle joints were selected as observation subjects and randomly divided into ankle blood flow restriction training combined with IASTM group (n=15), ankle blood flow restriction training alone (n=15), and traditional ankle strength training (n=15). The intervention lasted for 6 weeks, once a week. Cumberland ankle instability assessment, FAAM ankle function assessment score, and ankle range of motion measurement were performed at three time points before intervention, after the first intervention, and after 6 weeks of intervention for three groups. The ankle strength test was only compared and analyzed at two time points before and after intervention.
- Conditions
- Chronic Ankle Instability,CA
- Being tested
- Exercise Intervention, Instrument-Assisted Soft Tissue Mobilization, Tuinal
- Keywords
- Chronic Ankle Instability,CAI, Blood Flow Restriction Training，BFRT, Instrument-Assisted Soft Tissue Mobilization，IASTM, Tuina Massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Also called Blood Flow Restriction Training，BFRT
Blood Flow Restriction (BFR) training, also known as occlusion training or restricted blood flow training, involves applying external pressure to a limb using inflatable cuffs or elastic bands. This pressure partially restricts arterial blood flow while occluding venous blood flow in the pressured limb. The goal is to increase muscle strength and size by creating metabolic stress and promoting physiological adaptations, such as muscle hypertrophy, with lighter loads than traditional resistance training.
Instrument-Assisted Soft Tissue MobilizationBehavioural
Also called IASTM
Instrument-Assisted Soft Tissue Mobilization (IASTM) is a therapeutic technique that involves the use of specially designed tools or instruments to apply controlled mechanical pressure to soft tissues in the body. These tools are typically made of stainless steel or other materials and have various shapes and edges. The primary aim of IASTM is to address musculoskeletal conditions by breaking down scar tissue, fascial restrictions, and adhesions in the soft tissues. Practitioners use the instruments to detect and treat areas of tissue dysfunction, promoting improved range of motion, reduced pain, and enhanced functional mobility.
TuinalBehavioural
Also called massage
Tuinal, also known as Tui Na or Chinese therapeutic massage, is a traditional Chinese medicine (TCM) healing technique that involves manual manipulation of the body's soft tissues, including muscles and tendons. It is a form of bodywork that aims to balance the flow of vital energy (Qi) within the body and promote overall well-being. Tuina techniques may include kneading, rolling, pressing, and brushing, and they are applied to specific acupressure points or along the body's meridians. Tuina is used to address various health concerns, alleviate pain, improve circulation, and enhance the body's natural healing processes, making it an integral part of traditional Chinese medicine.
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction Training，BFRT | Experimental | Blood Flow Restriction Training (BFRT) is a special training technique aimed at limiting blood flow by using cuffs or elastic bands on the limbs to promote muscle growth and improve strength. BFRT was originally designed for rehabilitation injured athletes as it can improve muscle strength while reducing load, helping to avoid further injuries during the rehabilitation process. But as research deepens, it is gradually being applied to a wider range of fitness and training fields. One major advantage of BFRT is that it allows for efficient training under relatively light loads, reducing the burden on joints and tendons, making it suitable for people who find it difficult to withstand high-intensity training due to injuries or other reasons. Meanwhile, BFRT also has the characteristic of achieving muscle growth and strength growth in a short period of time, and it is considered a time-saving training method. BFRT can not only be used for strength training, but also for rehabilitation, i Receives: Behavioral: Exercise Intervention |
| Instrument-Assisted Soft Tissue Mobilization，IASTM | Experimental | Instrument Assisted Soft Tissue Mobilization (IASTM) is a physical therapy technique that utilizes specially designed tools (such as metal or plastic scraping boards) to assist in the treatment of soft tissue problems. Mainly used in rehabilitation medicine, sports medicine, and plastic surgery, it is used to handle tension, adhesion, pain, and motor dysfunction of muscles, fascia, and tendons. The edge design of IASTM special tools can loosen adhesions in tissues, improving their elasticity and plasticity. Regulating pathological areas through neural pathways, reducing pain and improving neurological function. And different types of treatment tools improve the accuracy of treatment, promote blood circulation, accelerate the rehabilitation process, improve tissue elasticity, expand joint range of motion, and have lower risks and complications compared to invasive surgery. Receives: Behavioral: Instrument-Assisted Soft Tissue Mobilization |
| Tuinal | Placebo comparator | Tuinal is an important physical therapy method in traditional Chinese medicine, which can be traced back to the Shang Dynasty around 2700 BC. With the continuous development of social economy and cultural exchange, Tuinal technology based on traditional Chinese medicine ethics and guided by modern scientific theories gradually emerged. The technical treatment methods are mainly relaxation techniques, supplemented by movement techniques. Following the principle of combining movement and stillness, emphasizing both muscles and bones, and progressing step by step, massage has significant therapeutic effects on skeletal muscle diseases. In clinical practice, massage therapists use various techniques to apply to specific parts or acupoints of the human body, keeping the nerves and muscle tissues in a good state, improving the unblocking of meridians, relaxing soft tissues, restoring flexibility, and relieving symptoms such as muscle spasms and pain. Receives: Behavioral: Tuinal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumberland Ankle Instability Tool，CAIT
Evaluated the patient's perception of ankle instability, including the frequency, CAIT typically includes a specific range of questions, each of which may have different scores. The total score is usually between 0 and 30 points, with higher scores indicating higher stability intensity, and impact of symptoms
Measured: 4-6week
Foot and Ankle Ability Measure（FAAM）
Foot and Ankle Ability Measure (FAAM) is a scale used to evaluate ankle joint function, which includes questions about pain, function, and quality of life, and can be used to assess the overall condition of patients with ankle instability. The functional score includes two types of assessments: the functional level of daily life (FAAM-ADL) and the functional level of physical activity (FAAM-SPORT). The score range is usually from 0 to 100, where 100 represents completely normal ankle joint function, and 0 represents extreme restriction or complete inability to use the ankle joint.
Measured: 4-6week
Ankle joint range of motion
This study used a high-precision joint motion angle measuring ruler to measure the range of motion of different ankle functions in both sitting and supine positions, including measurements of dorsiflexion and plantar flexion of the ankle, as well as measurements of varus and eversion of the foot. The larger the angle, the better the improvement in joint motion.
Measured: 4-6week
Ankle joint strength test
The experimental strength data was tested using a handheld digital muscle strength tester (model: FM-204M series muscle strength tester). The measurement unit of this muscle strength tester is N, with a measurement unit range of ± 50kgf and a measurement accuracy of ± 0.5% FS (range) ± 1 digital peak. The measured data includes both peak strength and instantaneous strength values. Therefore, this study used a handheld digital muscle strength tester, where participants sat in a suitable position, fixed the bottom of the instrument on the ground, and then applied force in different directions through their ankles. Measure the maximum force in the direction of dorsiflexion and plantarflexion of the ankle joint, abduction and eversion of the foot, and adduction and eversion. The strength test for each different exercise segment needs to be completed three times, and the average of the maximum strength values from the three tests is taken.
Measured: 4-6week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start20 Nov 2023
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle Instability,CAStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is no specific relevant model to refer to for use.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Liu, Wuhan Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251414
- Sponsor's protocol ID
- Wuhan Sport University
- Acronym
- CAI
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study requires me to conduct more experimental verification.
Publications
Liu Y, Wang Y. Study on the effect of blood flow restriction training combined with IASTAM on ankle strength and function intervention in athletes with chronic ankle instability in sport dance events. BMC Sports Sci Med Rehabil. 2024 Apr 11;16(1):81. doi: 10.1186/s13102-024-00873-x.
PubMed 38605396
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Blood Flow Restriction Training Combined With IASTAM on Symptoms in Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT06251414
- Acronym / sponsor ID
- CAI / Wuhan Sport University
- Conditions
- Chronic Ankle Instability,CA
- Keywords
- Chronic Ankle Instability,CAI, Blood Flow Restriction Training，BFRT, Instrument-Assisted Soft Tissue Mobilization，IASTM, Tuina Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Yang LiuUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 9 Feb 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.
Purpose; Through experimental observation of exercise intervention (blood flow restriction training combined with low load ankle muscle strength training and balance training) combined with instrument tool therapy (Instrument Soft Tissue Release Technique, IASTM), the intervention effect on ankle function, strength, and joint range of motion of sports dance athletes with ankle instability was observed.
Method; 45 subjects with unstable, restricted or uncomfortable ankle joints were selected as observation subjects and randomly divided into ankle blood flow restriction training combined with IASTM group (n=15), ankle blood flow restriction training alone (n=15), and traditional ankle strength training (n=15). The intervention lasted for 6 weeks, once a week. Cumberland ankle instability assessment, FAAM ankle function assessment score, and ankle range of motion measurement were performed at three time points before intervention, after the first intervention, and after 6 weeks of intervention for three groups. The ankle strength test was only compared and analyzed at two time points before and after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There is no specific relevant model to refer to for use.
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Training，BFRT | Experimental | Behavioral: Exercise InterventionBlood Flow Restriction Training (BFRT) is a special training technique aimed at limiting blood flow by using cuffs or elastic bands on the limbs to promote muscle growth and improve strength. BFRT was originally designed for rehabilitation injured athletes as it can improve muscle strength while reducing load, helping to avoid further injuries during the rehabilitation process. But as research deepens, it is gradually being applied to a wider range of fitness and training fields. One major advantage of BFRT is that it allows for efficient training under relatively light loads, reducing the burden on joints and tendons, making it suitable for people who find it difficult to withstand high-intensity training due to injuries or other reasons. Meanwhile, BFRT also has the characteristic of achieving muscle growth and strength growth in a short period of time, and it is considered a time-saving training method. BFRT can not only be used for strength training, but also for rehabilitation, i |
| Instrument-Assisted Soft Tissue Mobilization，IASTM | Experimental | Behavioral: Instrument-Assisted Soft Tissue MobilizationInstrument Assisted Soft Tissue Mobilization (IASTM) is a physical therapy technique that utilizes specially designed tools (such as metal or plastic scraping boards) to assist in the treatment of soft tissue problems. Mainly used in rehabilitation medicine, sports medicine, and plastic surgery, it is used to handle tension, adhesion, pain, and motor dysfunction of muscles, fascia, and tendons. The edge design of IASTM special tools can loosen adhesions in tissues, improving their elasticity and plasticity. Regulating pathological areas through neural pathways, reducing pain and improving neurological function. And different types of treatment tools improve the accuracy of treatment, promote blood circulation, accelerate the rehabilitation process, improve tissue elasticity, expand joint range of motion, and have lower risks and complications compared to invasive surgery. |
| Tuinal | Placebo comparator | Behavioral: TuinalTuinal is an important physical therapy method in traditional Chinese medicine, which can be traced back to the Shang Dynasty around 2700 BC. With the continuous development of social economy and cultural exchange, Tuinal technology based on traditional Chinese medicine ethics and guided by modern scientific theories gradually emerged. The technical treatment methods are mainly relaxation techniques, supplemented by movement techniques. Following the principle of combining movement and stillness, emphasizing both muscles and bones, and progressing step by step, massage has significant therapeutic effects on skeletal muscle diseases. In clinical practice, massage therapists use various techniques to apply to specific parts or acupoints of the human body, keeping the nerves and muscle tissues in a good state, improving the unblocking of meridians, relaxing soft tissues, restoring flexibility, and relieving symptoms such as muscle spasms and pain. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age: 18-35 years old
- Course of illness: Suffering from chronic ankle instability symptoms that last for at least 3 months
- Symptoms: Ankle instability, frequent ankle sprains, discomfort during walking or exercise
- Functional screening: Two or more tests tested positive for ankle joint function screening before the experiment
- Structural examination: No joint structural lesions or congenital ankle deformities,
Key exclusion criteria (9 listed)
- Under 18 years old or over 35 years old
- Acute ankle injury or no joint injury
- No ankle instability or unwillingness to cooperate with research requirements
- Failed ankle function screening
- Structural lesions or congenital ankle deformities present in the ankle joint
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 |
|---|---|---|
| Exercise InterventionAlso: Blood Flow Restriction Training，BFRTBlood Flow Restriction (BFR) training, also known as occlusion training or restricted blood flow training, involves applying external pressure to a limb using inflatable cuffs or elastic bands. This pressure partially restricts arterial blood flow while occluding venous blood flow in the pressured limb. The goal is to increase muscle strength and size by creating metabolic stress and promoting physiological adaptations, such as muscle hypertrophy, with lighter loads than traditional resistance training. | Behavioural | Blood Flow Restriction Training，BFRT |
| Instrument-Assisted Soft Tissue MobilizationAlso: IASTMInstrument-Assisted Soft Tissue Mobilization (IASTM) is a therapeutic technique that involves the use of specially designed tools or instruments to apply controlled mechanical pressure to soft tissues in the body. These tools are typically made of stainless steel or other materials and have various shapes and edges. The primary aim of IASTM is to address musculoskeletal conditions by breaking down scar tissue, fascial restrictions, and adhesions in the soft tissues. Practitioners use the instruments to detect and treat areas of tissue dysfunction, promoting improved range of motion, reduced pain, and enhanced functional mobility. | Behavioural | Instrument-Assisted Soft Tissue Mobilization，IASTM |
| TuinalAlso: massageTuinal, also known as Tui Na or Chinese therapeutic massage, is a traditional Chinese medicine (TCM) healing technique that involves manual manipulation of the body's soft tissues, including muscles and tendons. It is a form of bodywork that aims to balance the flow of vital energy (Qi) within the body and promote overall well-being. Tuina techniques may include kneading, rolling, pressing, and brushing, and they are applied to specific acupressure points or along the body's meridians. Tuina is used to address various health concerns, alleviate pain, improve circulation, and enhance the body's natural healing processes, making it an integral part of traditional Chinese medicine. | Behavioural | Tuinal |
Primary outcome
Cumberland Ankle Instability Tool，CAIT
Time frame: 4-6week
Evaluated the patient's perception of ankle instability, including the frequency, CAIT typically includes a specific range of questions, each of which may have different scores. The total score is usually between 0 and 30 points, with higher scores indicating higher stability intensity, and impact of symptoms
Foot and Ankle Ability Measure（FAAM）
Time frame: 4-6week
Foot and Ankle Ability Measure (FAAM) is a scale used to evaluate ankle joint function, which includes questions about pain, function, and quality of life, and can be used to assess the overall condition of patients with ankle instability. The functional score includes two types of assessments: the functional level of daily life (FAAM-ADL) and the functional level of physical activity (FAAM-SPORT). The score range is usually from 0 to 100, where 100 represents completely normal ankle joint function, and 0 represents extreme restriction or complete inability to use the ankle joint.
Ankle joint range of motion
Time frame: 4-6week
This study used a high-precision joint motion angle measuring ruler to measure the range of motion of different ankle functions in both sitting and supine positions, including measurements of dorsiflexion and plantar flexion of the ankle, as well as measurements of varus and eversion of the foot. The larger the angle, the better the improvement in joint motion.
Ankle joint strength test
Time frame: 4-6week
The experimental strength data was tested using a handheld digital muscle strength tester (model: FM-204M series muscle strength tester). The measurement unit of this muscle strength tester is N, with a measurement unit range of ± 50kgf and a measurement accuracy of ± 0.5% FS (range) ± 1 digital peak. The measured data includes both peak strength and instantaneous strength values. Therefore, this study used a handheld digital muscle strength tester, where participants sat in a suitable position, fixed the bottom of the instrument on the ground, and then applied force in different directions through their ankles. Measure the maximum force in the direction of dorsiflexion and plantarflexion of the ankle joint, abduction and eversion of the foot, and adduction and eversion. The strength test for each different exercise segment needs to be completed three times, and the average of the maximum strength values from the three tests is taken.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 38605396Liu Y, Wang Y. Study on the effect of blood flow restriction training combined with IASTAM on ankle strength and function intervention in athletes with chronic ankle instability in sport dance events. BMC Sports Sci Med Rehabil. 2024 Apr 11;16(1):81. doi: 10.1186/s13102-024-00873-x.
- Individual participant dataSharing planned: No. This study requires me to conduct more experimental verification.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Instrument-Assisted Soft Tissue Mobilization and Tuinal in people with Chronic Ankle Instability,CA, run by Yang Liu 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 9 Feb 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumberland Ankle Instability Tool，CAIT (time frame: 4-6week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06251414, which also lists 1 linked publication.
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 9 Feb 2024.