Effects of Hip Strength Training and Neuromuscular Electrical Stimulation on Functional Ankle Instability

April 9, 2024 updated by: Yanhua, Guo, Tianjin University of Sport

Study on the Effect of Hip Strength Training and Neuromuscular Electrical Stimulation on the Intervention of Functional Ankle Instability of Sport

The goal of this clinical trial is to compare the effects of two methods of elevating hip muscle strength on functional ankle instability(FAI). . The main question[s] it aims to answer are:

  • Whether hip strength training and neuromuscular electrical stimulation of the gluteal muscles, respectively, based on conventional ankle training improves dysfunction in patients with FAI?
  • Is there a difference in the efficacy of the above two interventions for FAI?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will be randomly divided into 3 groups (Experimental Group A, Experimental Group B and Control Group) to receive the intervention for 6 weeks. The Control Group will undergo conventional ankle interventions such as peri-ankle muscle strength training and ankle balance training; Experimental Group A will undergo hip muscle strength training based on the conventional training; and Experimental Group B will perform neuromuscular electrical stimulation of hip abductors and hip extensors based on the conventional training. Researchers will compare the three groups to see changes in hip muscle strength, lower extremity muscle activation, ankle muscle strength, proprioception, dynamic and static balance, and self-reported ankle function.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 301617
        • Tianjin University of Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of at least one acute ankle sprain one year ago, accompanied by symptoms such as pain, swelling, and inability to participate in daily activities for more than one day.
  • Unilateral ankle sprains and or instability felt at least twice during the past year.
  • Last ankle sprain occurred greater than or equal to 1 month from the start of the experiment.
  • Cumberland Ankle Instability Tool (CAIT) score less than or equal to 27 points,
  • The results of Medial Talar Tilt Test and Anterior Draw Test are negative.
  • Body Mass Index （BMI）ranges from 18 to 25.

Exclusion Criteria:

  • History of lower extremity surgery or fracture.
  • History of brain injury or neurological disorders.
  • Acute injury to musculoskeletal structures of other joints of the lower extremities within 1 month, affecting joint integrity and function.
  • Participated in lower extremity rehabilitation or systematic athletic training after injury.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
Participants in this group will receive conventional ankle interventions including ankle strength training and balance training. All treatments target the affected lower extremity for 40 minutes per session, once per day, 3 days per week for 6 weeks.
Procedure: Conventional ankle training
The program included ankle elastic band resistance training and balance training, in which the elastic band resistance training required subjects to complete resistance training in ankle plantarflexion, dorsiflexion, inversion and eversion directions with the help of elastic bands; and the balance training required subjects to complete the movements of standing with eyes open, standing with eyes closed, and throwing and catching the ball on flat ground and BOSU ball.
Experimental: Experimental Group A
Participants in this group will be asked to perform conventional ankle training and hip strength training. The conventional ankle training routine for this group will have the same movements as the control group, but the volume of training will be half that of the control group, and the duration of training will be 20 min/session. Hip strength training will consist of elastic band resistance exercises, forward step-up and lateral step-up for 20 min/session. All treatments target the affected lower extremity for 40 minutes per session, once per day, 3 days per week for 6 weeks.
Procedure: Conventional ankle training
The program included ankle elastic band resistance training and balance training, in which the elastic band resistance training required subjects to complete resistance training in ankle plantarflexion, dorsiflexion, inversion and eversion directions with the help of elastic bands; and the balance training required subjects to complete the movements of standing with eyes open, standing with eyes closed, and throwing and catching the ball on flat ground and BOSU ball.
Procedure: Hip strength training
Hip strength training required subjects to complete resistance training in hip abduction and posterior extension, anterior step-up and lateral step-up exercises with the help of elastic bands.
Experimental: Experimental Group B
Participants in this group will be asked to perform conventional ankle training and neuromuscular electrical stimulation. The conventional ankle training routine for this group will have the same movements as the control group, but the volume of training will be half that of the control group, and the duration of training will be 20 min/session. Neuromuscular electrical stimulation aims to stimulate the gluteus maximus and gluteus mediums muscles of the affected lower limb. The researcher chose the "Neuromuscular Electrical Stimulation 1" mode for the treatment prescription (this prescription can output a variety of waveforms with frequencies varying continuously from 1 to 100 Hz to stimulate the target muscles alternately, effectively preventing muscle fatigue caused by a single stimulation) and set the stimulation time to 20 min per session. All treatments target the affected lower extremity for 40 minutes per session, once per day, 3 days per week for 6 weeks.
Procedure: Conventional ankle training
The program included ankle elastic band resistance training and balance training, in which the elastic band resistance training required subjects to complete resistance training in ankle plantarflexion, dorsiflexion, inversion and eversion directions with the help of elastic bands; and the balance training required subjects to complete the movements of standing with eyes open, standing with eyes closed, and throwing and catching the ball on flat ground and BOSU ball.
Procedure: Neuromuscular electrical stimulation
Neuromuscular electrical stimulation of the gluteus mediums and gluteus maximus muscles of the affected side was carried out using the TB6807 low-frequency therapeutic instrument (with prescription for neuromuscular electrical stimulation) manufactured by China Tangbang Science and Technology Company.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cumberland Ankle Instability Tool (CAIT) score
Time Frame: Subjects were asked to test 1 time for 10 min before and after the intervention.
Using the CAIT score reflects the participant's subjective level of perceived stability of the ankle joint. The questionnaire contains 9 questions related to ankle function, mainly about ankle stability, pain and ankle sprains during daily activities, such as walking, running, descending stairs, and standing on one or two legs, with scores ranging from 0 to 30. The higher the score, the better the ankle stability.
Subjects were asked to test 1 time for 10 min before and after the intervention.
Dynamic and static balance
Time Frame: Subjects were asked to test 1 time for 20 min before and after the intervention.
The Tecnobody PK254P Balance Tester was used to perform static postural stability tests and dynamic postural stability tests to assess the subject's static and dynamic balance abilities. Static Postural Stability Test and Dynamic Postural Stability Test to assess the static and dynamic balance ability of the subjects. Static balance was measured by the pre The static balance ability was measured by the standard deviation in the forward and backward directions, the standard deviation in the left and right directions, the area of the movement ellipse and the circumference of the movement trajectory. The static balance ability was measured by the total stability index, anterior-posterior axis stability index, and left-right axis stability index.
Subjects were asked to test 1 time for 20 min before and after the intervention.
Muscle activation
Time Frame: Subjects were asked to test 1 time for 40 min before and after the intervention.
The electromyographic signals of gluteus medius, gluteus maximus, tibialis anterior, peroneus longus and gastrocnemius were collected by Noraxon ultium wireless surface electromyography to analyze the total amount of discharges of the motor units of the target muscles when the target muscles were involved in the activity, so as to reflect the degree of activation of the motor units of the target muscles in the course of the exercise. The test index is the Root Mean Square (RMS) of the target muscles before and after the landing moment of the single-leg vertical jump test.
Subjects were asked to test 1 time for 40 min before and after the intervention.
Joint position sense
Time Frame: Subjects were asked to test 1 time for 20 min before and after the intervention.
Plantarflexion, dorsiflexion, inversion and eversion joint positional perception tests in active mode at the affected ankle joint were performed using the Humac Norm Multi-Joint Isokinetic Test and Training System to assess the subject's proprioception. Absolute Errors (AE) between the values of the active inversion and active valgus position sense tests and the values requested by the tester were measured.
Subjects were asked to test 1 time for 20 min before and after the intervention.
Hip isometric strength
Time Frame: Subjects were asked to test 1 time for 20 min before and after the intervention.
The Humac Norm model multi-joint isokinetic testing apparatus was used to perform hip abductor and extensor strength on the affected side in order to assess the subject's hip abductor and extensor strength. Peak Torque (PT), Relative Peak Torque to Body Weight (PT/BW), and Total Work (TW) were measured during centripetal contraction at 60°/s and 180°/s angular velocities.
Subjects were asked to test 1 time for 20 min before and after the intervention.
Ankle isometric strength
Time Frame: Subjects were asked to test 1 time for 20 min before and after the intervention.
Ankle dorsiflexion, plantarflexion, inversion and valgus isokinetic strengths were measured using the Humac Norm Multi-Joint Isokinetic Testing Instrument. Peak Torque (PT), Relative Peak Torque to Body Weight (PT/BW), and Total Work (TW) were measured during centripetal contraction at 60°/s and 180°/s angular velocities.
Subjects were asked to test 1 time for 20 min before and after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin University of Sport

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wei Zheng, PhD, Tianjin University of Sport

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TianjinSport

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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