- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06682897
Simplified Tai Chi Exercises to Improve Function in People With Chronic Ankle Instability
The goal of this interventional trial is to evaluate the effectiveness of the simplified four-week Tai Chi training in improving function in people with chronic ankle instability. The main questions it aims to answer are:
- Does the 4-week Tai Chi training improve ankle neuromuscular responses?
- Does the 4-week Tai Chi training enhance ankle proprioception?
- Does the 4-week Tai Chi training improve ankle muscle strength?
- Does the 4-week Tai Chi training boost balance performance?
- Does the 4-week Tai Chi training enhance subjective ankle stability and quality of life?
Researchers will compare Tai Chi training to self-management to see if this Tai Chi training works to enhance ankle stability performance.
Participants will:
- Take self-management and Tai Chi training, and each for 4 weeks
- Visit the labs every 4 weeks for biomechanical measurements and questionnaires, totally 3 times.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Tai Chi is a traditional Chinese exercise practiced by millions worldwide to stay active and improve health. Based on muscle activation levels across the full set of movements (108 forms), we developed a simplified 16-form Tai Chi routine to enhance ankle stability for individuals with chronic ankle instability.
To evaluate the benefits of this simplified 16-form version for ankle function in people with chronic ankle instability, we are recruiting individuals managing symptoms of chronic ankle instability for a 4-week training program and assess their ankle-related function three times. All participants are randomly allocated to both the Tai Chi training group or a self-management control group, while maintaining their usual lifestyle and exercise routines throughout the study. All participants will complete the same training content and assessment tasks; participants in the control group will be offered the Tai Chi training following completion of the second outcome assessment.
The Tai Chi training includes a total of 12 sessions over 4 weeks, with three sessions per week, each lasting 1 hour (10 minutes of warm-up, 45 minutes of Tai Chi practice, and a 5-minute cool down). Each of the three functional assessments will include consistent measures, including muscle activation, proprioception, muscle strength, balance testing, and self-assessment scales (ankle function and quality of life).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Leicester
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Loughborough, Leicester, United Kingdom, LE113TU
- Loughborough University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Aged from 18 to 40
- A history of at least one significant lateral ankle sprain was associated with inflammatory symptoms (pain, swelling, etc) and disrupted activity
- The initial sprain must have occurred at least 12 months prior to study enrolment
- The most recent injury must have occurred more than 3 months prior to study enrolment
- Reports of feeling instable or "giving way" during daily activities or physical activities and experienced at least 2 episodes in the 6 months prior to study enrolment
- Scoring ≤25 on the Cumberland Ankle Instability Tool
Exclusion criteria:
- Any previous fractures or surgeries on the lower limbs
- Have other muscle, joint or nerve disorders that affect the function of the lower limbs
- Chest pain at rest, dizziness during rest, heart condition, or doctor's advice not to exercise without medical supervision
- Currently enrolled in other ankle rehabilitation programmes
- Already a Tai Chi practitioner
- Pregnant
- Allergic to adhesive tapes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Exercise
Participants will be asked to choose three time slots per week to come to the lab, and each time slot will consist of a 1-hour workout that includes a 10-minute warm-up, a 45-minute Tai Chi practice, and a 5-minute cool-down.
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60 minutes each session, three sessions per week, lasting 4 weeks for undertaking.
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No Intervention: Control
Participants replicated all the procedures of the exercise trial except for the different starting phase of the training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ankle neuromuscular reponses
Time Frame: From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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This includes two tasks, one is drop-landing, the other is ankle inversion perturbation.
Each side will perform each task three times.
Six electromyography muscle sensors will be placed on peroneus longus, peroneus brevis and tibialis anterior muscles to record muscle activity.
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From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ankle proprioception
Time Frame: From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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Proprioception will be tested using both the Humac Norm dynamometer and the trapdoor devices. Humac: Participants' ankles will be moved to inversion positions of 10 and 20 degrees and eversion positions of 10 and 15 degrees under the Humac device. The degrees of their active and passive replication will be recorded. Trapdoor: The tilt angle will be adjusted using four wooden blocks to 10, 12, 14, and 16 degrees. Each angle will be repeated randomly 10 times, totaling 40 trials. The perceived height number for each trial will be recorded. |
From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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Ankle muscle strength
Time Frame: From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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Ankle Muscle Strength will be assessed using the HUMAC Norm dynamometer.
The assessment of eversion will be conducted at a speed of 30°/s (eccentric and concentric), and inversion will be conducted at a speed of 60°/s (eccentric and concentric).
The peak of the participant's maximum effort three times will be recorded.
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From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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Balance performance
Time Frame: From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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Static balance: Participants are asked to complete three trials of unipedal stance on both limbs in both open and close eyes. A total of 12 trials are required, with each trial lasting for 10 s. Dynamic balance: SEBT: Three times each side. The most distal aspect of the great toe on 0 (crossroad of eight lines) during the entire procedure.The maximum distance (centimeters) for each reach direction is recorded. DLBT: Three times each side. All participants start by moving their right leg clockwise and their left leg counterclockwise to each direction. After jumping to an outer target, participants need to return to the center target and stabilise for two seconds, then jump again to an outer target. The total time will be recorded. |
From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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Questionnaire
Time Frame: From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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This includes the assessment of subjective ankle stability using the Cumberland Ankle Instability Tool and the Foot and Ankle Ability Measure questionnaire, as well as the evaluation of quality of life using the SF-12 questionnaire.
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From the date of randomization until the completion of three assessments. This evaluation will be conducted at 0, 4, and 8 weeks after enrollment, with a maximum duration of 8 weeks.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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