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Comparison of Passive and Active Joint Mobilization for Chronic Ankle Instability

Primary Purpose

Musculoskeletal Manipulations, Chronic Instability of Joint, Ankle Joint

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Active joint mobilization
Passive joint mobilization
Sponsored by
Sahmyook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Manipulations

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The better HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active Joint Mobilization

Passive Joint Mobilization

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2020
Last Updated
September 20, 2021
Sponsor
Sahmyook University
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1. Study Identification

Unique Protocol Identification Number
NCT04630899
Brief Title
Comparison of Passive and Active Joint Mobilization for Chronic Ankle Instability
Official Title
Comparison of Passive and Active Joint Mobilization for Chronic Ankle Instability: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2021 (Anticipated)
Primary Completion Date
December 10, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahmyook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Manipulations, Chronic Instability of Joint, Ankle Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Joint Mobilization
Arm Type
Experimental
Arm Title
Passive Joint Mobilization
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Active joint mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Passive joint mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ankle instability
Description
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.
Time Frame
4 weeks
Title
Range of motion
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Joong Kim, M.S.
Phone
+82-10-8005-1460
Email
doong18324@gmail.com
Facility Information:
Facility Name
The better Hospital
City
Gwangju
ZIP/Postal Code
61085
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Joong Kim, PhD student
Phone
+82-10-8005-1460
Email
doong18324@gmail.com

12. IPD Sharing Statement

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Comparison of Passive and Active Joint Mobilization for Chronic Ankle Instability

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