Musculoskeletal ManipulationsNCT04630899
Comparison of Passive and Active Joint Mobilization for Chronic Ankle Instability
A study testing Active joint mobilization and Passive joint mobilization in people with Musculoskeletal Manipulations and Chronic Instability of Joint, run by Sahmyook University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Musculoskeletal Manipulations, Chronic Instability of Joint, Ankle Joint
- What is being tested?
- Active joint mobilization and Passive joint mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Active joint mobilization, Passive joint mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active joint mobilizationOther
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 mobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Joint Mobilization | Experimental | Not described Receives: Other: Active joint mobilization |
| Passive Joint Mobilization | Experimental | Not described Receives: Other: Passive joint mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start30 Sep 2021
- Primary completion10 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal ManipulationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunjoong Kim, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630899
- Sponsor's protocol ID
- P01-202105-11-003
- Status last verified
- Feb 2025
- First submitted
- 8 Nov 2020
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Passive and Active Joint Mobilization for Chronic Ankle Instability: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04630899
- Acronym / sponsor ID
- P01-202105-11-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Joint Mobilization | Experimental | Other: Active joint mobilization |
| Passive Joint Mobilization | Experimental | Other: Passive joint mobilization |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active joint mobilizationThe 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. | Other | Active Joint Mobilization |
| Passive joint mobilizationPJM 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. | Other | Passive Joint Mobilization |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active joint mobilization and Passive joint mobilization in people with Musculoskeletal Manipulations and Chronic Instability of Joint, run by Sahmyook University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle instability (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.