Chronic Ankle InstabilityNCT06204861
The Effect of Capacitive and Resistive Electric Transfer Therapy in Chronic Ankle Instability Patients
A study testing Capacitive and Resistive Electric Transfer Therapy, Balance Training and Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy in people with Chronic Ankle Instability and Capacitive and Resistive Electric Transfer Therapy, run by Beijing Sport University at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the applicability and effectiveness of capacitive and resistive Electric transfer (CRET) therapy in combination with balance training in improving ankle function, proprioception, and balance in patients with chronic ankle instability (CAI). Read more about this study
- Who is it for?
- Ages 18 to 22 years
- Conditions the study is for
- Chronic Ankle Instability, Capacitive and Resistive Electric Transfer Therapy
- What is being tested?
- Capacitive and Resistive Electric Transfer Therapy, Balance Training and Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 15 Oct 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 22 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 years;
- At least 12 months between the initial sprain and the current experiment, the sprain occurred with symptoms of inflammatory reactions such as pain and swelling, resulting in the inability to engage in physical activity for at least 1 day, and the most recent ankle sprain was more than 3 months away from the experiment;
- The occurrence of a re-sprain or "sensory instability" condition after the initial sprain, as follows: a. "sensory instability": at least 2 times within 6 months from the experiment; b. re-sprain: 2 times or 2 times of the same ankle sprain " condition as follows: a. "Sensory destabilization": at least 2 times within 6 months from the experiment; b. Re-sprain: 2 or more sprains of the same ankle;
- Ankle Joint Functional Assessment Tool (AJFAT) score ≤ 26;
- No complaint of instability in the other ankle;
- No mechanical ankle instability, i.e., negative anterior drawer test and talar tilt test
- No intervention by any means of rehabilitation before participation in this experiment.
Who cannot join
- The presence of lower extremity fracture on either side;
- The presence of central or peripheral nervous system injury
- The presence of lower extremity surgery on either side.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Study of Capacitive and Resistive Electric Transfer Therapy Combined With Balance Training on Chronic Ankle Instability
The goal of this clinical trial is to compare the applicability and effectiveness of capacitive and resistive Electric transfer (CRET) therapy in combination with balance training in improving ankle function, proprioception, and balance in patients with chronic ankle instability (CAI). The main questions it aims to answer are:
- Can CRET therapy expedite the rehabilitation process for patients with chronic ankle instability?
- Does the combination of CRET therapy and balance training yield superior efficacy to other interventions?
This study involved 31 physically active participants with unilateral ankle instability, comprising 19 males and 12 females. The participants were randomly assigned to one of three groups: the balance training group (B Group), the capacitive and resistive electric transfer group (CRET Group), and the balance training combined with the capacitive and resistive electric transfer group (B+CRET Group).
Read the detailed description
B group received only the balance training program, CRET group received only the CRET therapy, and B+CRET group received both the balance training program and the CRET therapy. Each intervention group received 12 interventions, three times per week, for a total of four weeks. Participants were instructed not to participate in any other exercise or treatment program during the experiment. Measurements were taken by the same researcher before and after the intervention. All participants were fully informed of the experiment's purpose and procedures and provided voluntary informed consent to participate. 31 participants completed the experimental study three times per week for four weeks under the guidance of a physical therapist. Only data from individuals with a completion rate of 75% or higher were included in the analysis.
The technical line of this study was to collect basic information about the participants, including age, height, weight, injury history, etc., and perform Ankle Special Tests, One Leg Standing Test, modified Star Excursion Balance Test, and fill out the Ankle Joint Functional Assessment Tool. Then the intervention groups underwent 12 sessions. In both the CRET and B+CRET groups, participants received a 10-minute intervention in CAP mode followed by a 20-minute intervention in RES mode. However, the B+CRET group received balance training along with CRET treatment.
The data was processed and analysed using SPSS 29.0 and Excel before and after the experiment. For count data that conformed to a normal distribution, mean ± standard deviation was used to express them. One-way ANOVA was used to analyse pre- and post-intervention between-group differences, with two-way comparisons using Tukey's test. Paired-sample t-tests were used to analyse pre- and post-intervention within-group differences. The Kruskal-Wallis H test was used to analyse pre- and post-intervention between-group differences for data that did not conform to a normal distribution. Similarly, the Wilcoxon signed-rank test was used to analyse pre- and post-intervention within-group differences. A significant difference was indicated by P<0.05 for all statistical results.
- Being tested
- Capacitive and Resistive Electric Transfer Therapy, Balance Training, Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capacitive and Resistive Electric Transfer TherapyOther
Participants received a 10-minute intervention in CAP mode followed by a 20-minute intervention in RES mode.
Balance TrainingOther
The training program consists of five exercises: single-limb stance, single-limb stance with ball toss, single-limb stance with kicking, step-down with a single-limb stance, and wobble board. The program is conducted three times a week, and the difficulty level is increased every two weeks. Before and following the training, a physiotherapist will lead a warm-up and stretching session.
Balance Training Combined with Capacitive and Resistive Electric Transfer TherapyOther
Participants received a 10-minute intervention in CAP mode followed by a 20-minute intervention in RES mode. However, the B+CRET group received balance training along with CRET treatment.
| Study group | Role | What they receive |
|---|---|---|
| Capacitive and Resistive Electric Transfer Therapy Group | Experimental | Participants underwent 30 minutes of treatment per session, three times per week for four weeks during the experiment. Receives: Other: Capacitive and Resistive Electric Transfer Therapy |
| Balance Training Group | Experimental | Participants underwent 30 minutes of training per session, three times per week for four weeks during the experiment. Receives: Other: Balance Training |
| Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy Group | Experimental | Participants underwent 30 minutes of training and treatment per session, three times per week for four weeks during the experiment. Receives: Other: Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Joint Functional Assessment Tool
The Ankle Joint Functional Assessment Tool (AJFAT) can accurately identify functional instability. It consists of a 12-item self-assessment of pain and swelling, the ability to walk on stairs and uneven surfaces, make sharp stops and changes in direction, muscle strength, and stability. Participants evaluated the affected lower limb in comparison to the healthy limb using a grading system with five levels (0-4 points each), resulting in a maximum score of 48 points. Scores of 26 or lower were considered indicative of functional ankle instability and were included in the study. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the twelfth intervention training (4 weeks after the first intervention).
One Leg Standing Test
The participant stood with their affected foot closed and their contralateral knee flexed at 90°. A score of one was recorded if any of the following occurred: the participant's supporting foot shifted, the contralateral lower extremity touched the ground, or the body swung beyond the center. The patient's total score within half-minute was recorded. Three tests were performed, and the average value was calculated. Subjects removed their shoes and socks to eliminate tactile effects. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the twelfth intervention training (4 weeks after the first intervention).
The modified Star Excursion Balance Test
The participant was instructed to extend the unsupported leg as far as possible in three directions while balancing on one leg. Before the test, the length of the lower limb was measured from the anterior superior iliac spine to the lower end of the medial tibial ankle using a vernier straightedge while the participant was lying flat. To prevent learning effects, each participant practiced each direction six times before the formal test. The evaluation index chosen was relative distance, which is calculated as the maximum distance extended in each direction divided by the length of the leg and multiplied by 100. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the twelfth intervention training (4 weeks after the first intervention). The time, place, and testers of the test were kept consistent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Mar 2023
- Primary completion31 Jul 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Song, Principal investigator, Beijing Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204861
- Sponsor's protocol ID
- 2023341H
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Study of Capacitive and Resistive Electric Transfer Therapy Combined With Balance Training on Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT06204861
- Acronym / sponsor ID
- 2023341H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 12 Jan 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.
The goal of this clinical trial is to compare the applicability and effectiveness of capacitive and resistive Electric transfer (CRET) therapy in combination with balance training in improving ankle function, proprioception, and balance in patients with chronic ankle instability (CAI). The main questions it aims to answer are:
- Can CRET therapy expedite the rehabilitation process for patients with chronic ankle instability?
- Does the combination of CRET therapy and balance training yield superior efficacy to other interventions?
This study involved 31 physically active participants with unilateral ankle instability, comprising 19 males and 12 females. The participants were randomly assigned to one of three groups: the balance training group (B Group), the capacitive and resistive electric transfer group (CRET Group), and the balance training combined with the capacitive and resistive electric transfer group (B+CRET Group).
Detailed description
B group received only the balance training program, CRET group received only the CRET therapy, and B+CRET group received both the balance training program and the CRET therapy. Each intervention group received 12 interventions, three times per week, for a total of four weeks. Participants were instructed not to participate in any other exercise or treatment program during the experiment. Measurements were taken by the same researcher before and after the intervention. All participants were fully informed of the experiment's purpose and procedures and provided voluntary informed consent to participate. 31 participants completed the experimental study three times per week for four weeks under the guidance of a physical therapist. Only data from individuals with a completion rate of 75% or higher were included in the analysis.
The technical line of this study was to collect basic information about the participants, including age, height, weight, injury history, etc., and perform Ankle Special Tests, One Leg Standing Test, modified Star Excursion Balance Test, and fill out the Ankle Joint Functional Assessment Tool. Then the intervention groups underwent 12 sessions. In both the CRET and B+CRET groups, participants received a 10-minute intervention in CAP mode followed by a 20-minute intervention in RES mode. However, the B+CRET group received balance training along with CRET treatment.
The data was processed and analysed using SPSS 29.0 and Excel before and after the experiment. For count data that conformed to a normal distribution, mean ± standard deviation was used to express them. One-way ANOVA was used to analyse pre- and post-intervention between-group differences, with two-way comparisons using Tukey's test. Paired-sample t-tests were used to analyse pre- and post-intervention within-group differences. The Kruskal-Wallis H test was used to analyse pre- and post-intervention between-group differences for data that did not conform to a normal distribution. Similarly, the Wilcoxon signed-rank test was used to analyse pre- and post-intervention within-group differences. A significant difference was indicated by P<0.05 for all statistical results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Capacitive and Resistive Electric Transfer Therapy Group | Experimental | Other: Capacitive and Resistive Electric Transfer TherapyParticipants underwent 30 minutes of treatment per session, three times per week for four weeks during the experiment. |
| Balance Training Group | Experimental | Other: Balance TrainingParticipants underwent 30 minutes of training per session, three times per week for four weeks during the experiment. |
| Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy Group | Experimental | Other: Balance Training Combined with Capacitive and Resistive Electric Transfer TherapyParticipants underwent 30 minutes of training and treatment per session, three times per week for four weeks during the experiment. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ≥18 years;
- At least 12 months between the initial sprain and the current experiment, the sprain occurred with symptoms of inflammatory reactions such as pain and swelling, resulting in the inability to engage in physical activity for at least 1 day, and the most recent ankle sprain was more than 3 months away from the experiment;
- The occurrence of a re-sprain or "sensory instability" condition after the initial sprain, as follows: a. "sensory instability": at least 2 times within 6 months from the experiment; b. re-sprain: 2 times or 2 times of the same ankle sprain " condition as follows: a. "Sensory destabilization": at least 2 times within 6 months from the experiment; b. Re-sprain: 2 or more sprains of the same ankle;
- Ankle Joint Functional Assessment Tool (AJFAT) score ≤ 26;
- No complaint of instability in the other ankle;
Key exclusion criteria (3 listed)
- The presence of lower extremity fracture on either side;
- The presence of central or peripheral nervous system injury
- The presence of lower extremity surgery on either side.
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 |
|---|---|---|
| Capacitive and Resistive Electric Transfer TherapyParticipants received a 10-minute intervention in CAP mode followed by a 20-minute intervention in RES mode. | Other | Capacitive and Resistive Electric Transfer Therapy Group |
| Balance TrainingThe training program consists of five exercises: single-limb stance, single-limb stance with ball toss, single-limb stance with kicking, step-down with a single-limb stance, and wobble board. The program is conducted three times a week, and the difficulty level is increased every two weeks. Before and following the training, a physiotherapist will lead a warm-up and stretching session. | Other | Balance Training Group |
| Balance Training Combined with Capacitive and Resistive Electric Transfer TherapyParticipants received a 10-minute intervention in CAP mode followed by a 20-minute intervention in RES mode. However, the B+CRET group received balance training along with CRET treatment. | Other | Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy Group |
Primary outcome
Ankle Joint Functional Assessment Tool
Time frame: Each subject was tested before the first intervention training and after the twelfth intervention training (4 weeks after the first intervention).
The Ankle Joint Functional Assessment Tool (AJFAT) can accurately identify functional instability. It consists of a 12-item self-assessment of pain and swelling, the ability to walk on stairs and uneven surfaces, make sharp stops and changes in direction, muscle strength, and stability. Participants evaluated the affected lower limb in comparison to the healthy limb using a grading system with five levels (0-4 points each), resulting in a maximum score of 48 points. Scores of 26 or lower were considered indicative of functional ankle instability and were included in the study. The time, place, and testers of the test were kept consistent.
One Leg Standing Test
Time frame: Each subject was tested before the first intervention training and after the twelfth intervention training (4 weeks after the first intervention).
The participant stood with their affected foot closed and their contralateral knee flexed at 90°. A score of one was recorded if any of the following occurred: the participant's supporting foot shifted, the contralateral lower extremity touched the ground, or the body swung beyond the center. The patient's total score within half-minute was recorded. Three tests were performed, and the average value was calculated. Subjects removed their shoes and socks to eliminate tactile effects. The time, place, and testers of the test were kept consistent.
The modified Star Excursion Balance Test
Time frame: Each subject was tested before the first intervention training and after the twelfth intervention training (4 weeks after the first intervention). The time, place, and testers of the test were kept consistent.
The participant was instructed to extend the unsupported leg as far as possible in three directions while balancing on one leg. Before the test, the length of the lower limb was measured from the anterior superior iliac spine to the lower end of the medial tibial ankle using a vernier straightedge while the participant was lying flat. To prevent learning effects, each participant practiced each direction six times before the formal test. The evaluation index chosen was relative distance, which is calculated as the maximum distance extended in each direction divided by the length of the leg and multiplied by 100. The time, place, and testers of the test were kept consistent.
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 5 Jan 2026.
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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.
Lin Song principal investigator
Beijing Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capacitive and Resistive Electric Transfer Therapy, Balance Training and Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy in people with Chronic Ankle Instability and Capacitive and Resistive Electric Transfer Therapy, run by Beijing Sport University 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 7 inclusion and 3 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 5 Jan 2026. 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?
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?
Ankle Joint Functional Assessment Tool (time frame: Each subject was tested before the first intervention training and after the twelfth intervention training (4 weeks after the first intervention).). 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 5 Jan 2026.