Effect of PNF Training as an Intervention for Functional Ankle Instability in College Student

March 14, 2024 updated by: Ma Shuzhen
The lower limb stability test was carried out by MicroSwing 6.0 gravity center moving trajectory tester made in Germany.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

The test steps and methods are as follows:

  1. Before the test, arrange the subjects to be familiar with the lower limb stability test system and test environment, and master the test method.
  2. The subject stands barefoot and one foot in the center of the center of gravity movement trajectory tester, with his hands placed on his sides naturally, and maintains his body balance for 30 seconds.
  3. Record data of the test system.
  4. The measurement was repeated three times with a time interval of 5min. Collect the test data of the center of gravity moving trajectory tester, including swing frequency, coordination coefficient and stability coefficient, and get the best results of the three tests. The smaller the oscillation frequency and coordination coefficient are within a certain range, the better the stability is. The greater the value of stability coefficient is within a certain range, the better the stability is.

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 (Estimated)

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.
30

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Yes

Description

Inclusion Criteria:

  1. Unilateral functional ankle instability;
  2. Have not received formal rehabilitation treatment or informal rehabilitation treatment within the past month;
  3. Voluntarily accept the treatment in this study and ensure to complete the training tasks arranged by the therapist;
  4. Aged between 18 and 23 years old;

Exclusion Criteria:

  1. Does not meet the above diagnostic criteria;
  2. Ankle pain caused by infectious diseases;
  3. suffering from severe neurological diseases;
  4. Soft tissue damage near the ankle joint;
  5. Other joints outside the ankle are unstable.

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: Basic Science
  • 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.
Experimental: PNF training group
The experimental group will undergo 60 minutes of PNF training.
Other: PNF training
The subjects underwent rehabilitation training for 8 weeks, three times a week (Monday, Wednesday and Friday, 6:00 PM to 10:00 PM in the Physical Education College of Guangxi Normal University), and the rehabilitation training time was about 40-45 minutes per person. Before each rehabilitation training, the subjects warmed up the ankle and lower leg muscles for 5 minutes, followed by the corresponding rehabilitation training for 30-35 minutes, and relaxed the ankle and lower leg muscles for 5 minutes after the training.
Other: Control training group
The control group will follow the curriculum standards set by the Sports University.
Other: PNF training
The subjects underwent rehabilitation training for 8 weeks, three times a week (Monday, Wednesday and Friday, 6:00 PM to 10:00 PM in the Physical Education College of Guangxi Normal University), and the rehabilitation training time was about 40-45 minutes per person. Before each rehabilitation training, the subjects warmed up the ankle and lower leg muscles for 5 minutes, followed by the corresponding rehabilitation training for 30-35 minutes, and relaxed the ankle and lower leg muscles for 5 minutes after the training.

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
CAIT score
Time Frame: Baseline, post-test after 8 weeks

CAIT consists of 9 questions with a total of 30 points, scoring ≦27 points for diagnosis of functional ankle instability, 28 points and above for diagnosis of non-functional ankle instability.

  1. Before issuing the questionnaire, explain the contents of the questionnaire to the subjects in detail, and the subjects fill in the questionnaire truthfully according to their own situation.
  2. The CAIT score of the subjects was calculated and recorded.
  3. If you fill in the questionnaire incorrectly, you need to fill it again and keep a record
Baseline, post-test after 8 weeks
Lower limb stability test
Time Frame: Baseline, post-test after 8 weeks

The lower limb stability test was carried out by MicroSwing 6.0 gravity center moving trajectory tester made in Germany. The test steps and methods are as follows:

  1. Before the test, arrange the subjects to be familiar with the lower limb stability test system and test environment, and master the test method.
  2. The subject stands barefoot and one foot in the center of the center of gravity movement trajectory tester, with his hands placed on his sides naturally, and maintains his body balance for 30 seconds.
  3. Record data of the test system.
  4. The measurement was repeated three times with a time interval of 5min. Collect the test data of the center of gravity moving trajectory tester, including swing frequency, coordination coefficient and stability coefficient, and get the best results of the three tests.
Baseline, post-test after 8 weeks
Star offset balance test
Time Frame: Baseline, post-test after 8 weeks

The subjects stood in the center of the star chart with the affected side foot as the supporting foot, with bare feet and one foot in the center. The healthy side foot was extended forward, outward front, outer front, outer back, back, inner back, inner and inner front respectively to the farthest distance as far as possible. The supporting foot was extended in the counterclockwise direction when the left foot was used, and the supporting foot was extended in the clockwise direction when the right foot was used. The subject withdrew the non-supporting foot and resumed standing with both feet and rested for 5 seconds. The data of each extension of the subject was recorded, and the farthest score was measured three times. The furthest results in each direction were standardized with the subjects' lower limb length, and the data were recorded.

(4) The furthest scores in each direction were standardized with the subjects' lower limb length, and the data were recorded.
Baseline, post-test after 8 weeks
Muscle strength test
Time Frame: Baseline, post-test after 8 weeks

MicroFET2 hand-held muscle strength tester made in Germany was used for muscle strength test. The test steps and methods are as follows:

  1. Before the test, arrange the subjects to be familiar with the handheld muscle strength test system and test environment, and master the test method.
  2. The subject took off his shoes and socks and lay on his back on the recovery bed with his hands naturally placed on his chest. The muscle strength of the subject's dorsalis, plantar flexus, varus and valgus were tested respectively.
  3. Record data of the test system.
  4. The measurement was repeated 5 times in each direction of movement. The test data of handheld muscle strength tester were collected, including the muscle strength of ankle dorsiflexion, plantar flexion, varus and valgus, and the best results of 5 tests were obtained.
Baseline, post-test after 8 weeks

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.
Ma Shuzhen

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 (Estimated)

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.
March 30, 2024

Primary Completion (Estimated)

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.
May 30, 2024

Study Completion (Estimated)

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.
June 20, 2024

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).
March 5, 2024

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.
March 5, 2024

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.
March 13, 2024

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.
March 15, 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.
March 14, 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.
March 1, 2024

More Information

Terms related to this study

Keywords

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.
  • Shuzhen Ma

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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