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Completed

NCT Number: NCT06251414

Study on the Effect of Exercise Intervention Combined With Physical Therapy on Chronic Ankle Instability Symptoms

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.

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Key information

Conditions

Chronic Ankle Instability,CA

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YangLiu

Wuhan, Hubei, 430079, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Exercise Intervention

Behavioral

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.

Other names: Blood Flow Restriction Training，BFRT

Instrument-Assisted Soft Tissue Mobilization

Behavioral

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.

Other names: IASTM

Tuinal

Behavioral

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.

Other names: massage

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Yang Liu

Other

Registry information

Official study title

Study on the Effect of Blood Flow Restriction Training Combined With IASTAM on Symptoms in Patients With Chronic Ankle Instability

Acronym: CAI

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2024
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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