NCT04630899

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

November 8, 2020

Last Update Submit

February 18, 2025

Conditions

Musculoskeletal ManipulationsChronic Instability of JointAnkle Joint

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Active Joint Mobilization

EXPERIMENTAL
Other: Active joint mobilization

Passive Joint Mobilization

EXPERIMENTAL
Other: Passive joint mobilization

Interventions

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.

Active Joint Mobilization
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.

Passive Joint Mobilization

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gwangju Health University

Gwangju, 62287, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2020

First Posted

November 16, 2020

Study Start

September 30, 2021

Primary Completion

December 10, 2021

Study Completion

December 30, 2021

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations

KR(1)