NCT04957810

Brief Summary

Based on the home rehabilitation exercise of patients undergoing ACL reconstruction, the existing WeChat applet of sports medicine of the Third Hospital of Beijing Medical University is optimized to be used as a health education tool to guide patients undergoing home rehabilitation exercise after ACL reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

June 25, 2021

Last Update Submit

July 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in range of motion of knee joint

    Changes in range of motion of the knee between two time points

    2 weeks, 6 weeks and 12 weeks after surgery

Secondary Outcomes (2)

  • Visual pain score during knee motion angle exercise

    2 weeks, 6 weeks and 12 weeks after surgery

  • SF-12 quality of life scale

    2 weeks, 6 weeks and 12 weeks after surgery

Study Arms (2)

Patients who are given regular home functional exercises and discharged from the hospital

NO INTERVENTION

Discharge guidance using regular home function exercises, that is, existing regular missions and paper-based brochures

Patients who are guided by conventional discharge guidance and the optimized WeChat official account

ACTIVE COMPARATOR

Use regular discharge guidance and optimized WeChat public account guidance

Behavioral: WeChat Mini Program

Interventions

Through the WeChat applet, it provides services such as visit content configuration, self-image configuration, self-image measurement configuration, and visit reminders.

Patients who are guided by conventional discharge guidance and the optimized WeChat official account

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 years old (including 18 years old) and 45 years old;
  • Patients who underwent simple ACL reconstruction for the first time, combined with cartilage trimming and partial meniscus resection, and had the same postoperative rehabilitation plan;
  • Those who have basic literacy and communication skills;
  • Those who have a smartphone, can use WeChat or can learn to use WeChat;

You may not qualify if:

  • Have a history of joint infection, joint tuberculosis or osteomyelitis, or have undergone surgery in the lower limbs within 6 months;
  • Combined with severe heart, brain, kidney, and other organ dysfunction;
  • Patients with other severe knee joint disease injuries;
  • The patient is accompanied by mental illness or cognitive impairment, unable to study and participate in rehabilitation training;
  • Those who have participated in other similar rehabilitation function training programs, or transferred to other medical institutions for rehabilitation after being discharged from the hospital;
  • Those who have not signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • yuping yang

    Peking University Third Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 12, 2021

Study Start

March 1, 2019

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

July 12, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations