The Effect of Capacitive and Resistive Electric Transfer Therapy in Chronic Ankle Instability Patients

NCT06204861 | Completed

• 1 other identifier: 2023341H
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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). 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).

Conditions

Chronic Ankle Instability; Capacitive and Resistive Electric Transfer Therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

Study Arms (3)

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.

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.

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.

Other: Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy

Interventions

Balance Training OTHER

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 Group

Capacitive and Resistive Electric Transfer Therapy OTHER

Participants received a 10-minute intervention in CAP mode followed by a 20-minute intervention in RES mode.

Capacitive and Resistive Electric Transfer Therapy Group

Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy OTHER

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.

Balance Training Combined with Capacitive and Resistive Electric Transfer Therapy Group

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Sport University: lead

Study Sites (1)

Beijing Sport University

Beijing, Beijing Municipality, 100084, China

Location

Study Officials

• Lin Song

  Beijing Sport University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: March 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: October 15, 2023
• Last Updated: January 5, 2026

Record last verified: 2024-01

Locations

CN (1)