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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06308809
Other study ID # Shuzhen Ma
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 30, 2024
Est. completion date June 20, 2024

Study information

Verified date March 2024
Source Universiti Putra Malaysia
Contact Shuzhen Ma
Phone 18377336078
Email msz20210607@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 20, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 23 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ma Shuzhen

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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.
The CAIT score of the subjects was calculated and recorded.
If you fill in the questionnaire incorrectly, you need to fill it again and keep a record
Baseline, post-test after 8 weeks
Primary 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:
Before the test, arrange the subjects to be familiar with the lower limb stability test system and test environment, and master the test method.
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.
Record data of the test system.
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
Primary 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
Primary 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:
Before the test, arrange the subjects to be familiar with the handheld muscle strength test system and test environment, and master the test method.
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.
Record data of the test system.
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
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