- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04630899
Comparison of Passive and Active Joint Mobilization for Chronic Ankle Instability
September 20, 2021 updated by: Hyun-Joong Kim, Sahmyook University
Comparison of Passive and Active Joint Mobilization for Chronic Ankle Instability: A Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- 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
- Name: Hyun-Joong Kim, M.S.
- Phone Number: +82-10-8005-1460
- Email: doong18324@gmail.com
Study Locations
-
-
-
Gwangju, Korea, Republic of, 61085
- Recruiting
- The Better Hospital
-
Contact:
- Hyun-Joong Kim, PhD student
- Phone Number: +82-10-8005-1460
- Email: doong18324@gmail.com
-
-
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
Ages Eligible for Study
19 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle instability
Time Frame: 4 weeks
|
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
|
Range of motion
Time Frame: 4 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
September 30, 2021
Primary Completion (ANTICIPATED)
December 10, 2021
Study Completion (ANTICIPATED)
December 30, 2021
Study Registration Dates
First Submitted
November 8, 2020
First Submitted That Met QC Criteria
November 13, 2020
First Posted (ACTUAL)
November 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 22, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P01-202105-11-003
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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