NCT06308809

Brief Summary

The lower limb stability test was carried out by MicroSwing 6.0 gravity center moving trajectory tester made in Germany.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 5, 2024

Last Update Submit

March 14, 2024

Conditions

Keywords

adolescent populationPNF training

Outcome Measures

Primary Outcomes (4)

  • CAIT score

    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

    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

    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

    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

Study Arms (2)

PNF training group

EXPERIMENTAL

The experimental group will undergo 60 minutes of PNF training.

Other: PNF training

Control training group

OTHER

The control group will follow the curriculum standards set by the Sports University.

Other: PNF training

Interventions

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.

Control training groupPNF training group

Eligibility Criteria

Age18 Years - 23 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant) \- Page 2 of 5 \[DRAFT\] -In order to avoid mutual interference between the experimental group and the control group, a blinding method needs to be used in the study. In this study, a single blind experiment will be conducted to blind the participating athletes. During the sample grouping process, participating athletes will not know the specific grouping situation.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 13, 2024

Study Start

March 30, 2024

Primary Completion

May 30, 2024

Study Completion

June 20, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share