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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04630899
Other study ID # P01-202105-11-003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2021
Est. completion date December 30, 2021

Study information

Verified date September 2021
Source Sahmyook University
Contact Hyun-Joong Kim, M.S.
Phone +82-10-8005-1460
Email doong18324@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The features of CAI were confirmed through studies that 64% to 77% had extra-articular conditions mainly related to calf tendon disorder. In addition, joints are laxity, sensory motors are deficient, and the range of dorsi flexion is decreased. this study is to investigate the effects of active joint mobilization(AJM) under weight-bearing conditions to stimulate various proprioceptors for CAI with deficiency in sensorimotor and postural control.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 30, 2021
Est. primary completion date December 10, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 60 Years
Eligibility Inclusion Criteria: - First ankle sprain one year before clinical trial - A score of less than 24 on the Cumberland Ankle Instability Tool (CAIT) - No ankle sprains occurred within 4 weeks of starting the test - Two or more more ankle sprains in the past month Exclusion Criteria: - If you have a history of lower extremity surgery - In case of receiving treatment for the affected ankle within 1 month - If you have a psychological problem

Study Design


Intervention

Other:
Active joint mobilization
The participants bend his knees in a prone position. The physical therapist holds the medial malleolus with one hand and the lateral malleolus with the other. At the same time, the physical therapist touches the participant's soles to the sternum area and presses them in the dorsal direction. At this time, medial malleolus glides anterior and lateral malleolus glides posterior. The first procedure is to passively recognize movement. The second procedure is accompanied by active movement of the participant.
Passive joint mobilization
PJM uses Maitland's Mobilization method, grade III (high amplitude in the end range of the joint and 1 second vibration in the middle range through linear motion in which tissue resistance is felt). The participant is in a supine position, and the physical therapist holds the talus with one hand and the tibia with the other hand, and performs joint mobilization in the posterior direction with the hand holding the talus.

Locations

Country Name City State
Korea, Republic of The better Hospital Gwangju

Sponsors (1)

Lead Sponsor Collaborator
Sahmyook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ankle instability Consists of 9 questions, 3 to 0 points for 5 questions, 4 to 0 points for 2 questions, 5 to 0 points for 1 question, and 2 to 0 points for another question. A total score of 30 points is the highest, 28 points or more are stable ankle joints, and 24 points or less are unstable ankle joints. The higher the score, the closer to normal, and the lower the score, the lower the stability. 4 weeks
Primary Range of motion Measured based on the accelerometer sensor built into the mobile phone with a clinometer app. After fixing the mobile phone on the participant's sole, press "0 clear" to calibrate it to the initial value. The physical therapist asks the participant to "flex the foot in the dorsal direction " Measure a total of 2 times and record it as an average value. 4 weeks
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