The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction
1 other identifier
interventional
60
1 country
1
Brief Summary
To develop new prevention programs for non-contact ACL injuries that do not require additional training time and assistance from a sports medicine professional personnel. A knee extension constraint will be utilized to patients who have undertaken ACL reconstruction. And to determine the effects of knee extension constraint rehabilitation on lower extremity biomechanics after ACL reconstruction surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
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
July 28, 2016
CompletedFirst Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 9, 2020
June 1, 2020
4.4 years
June 30, 2020
July 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
walking speed
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 24 weeks after ACL reconstruction surgery.
walking speed
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 36 weeks after ACL reconstruction surgery.
walking speed
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 48 weeks after ACL reconstruction surgery.
ground reaction force
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 24 weeks after ACL reconstruction surgery.
ground reaction force
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 36 weeks after ACL reconstruction surgery.
ground reaction force
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 48 weeks after ACL reconstruction surgery.
knee flexion angle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 24 weeks after ACL reconstruction surgery.
knee flexion angle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 36 weeks after ACL reconstruction surgery.
knee flexion angle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 48 weeks after ACL reconstruction surgery.
the moment of knee extension in the gait cycle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 24 weeks after ACL reconstruction surgery.
the moment of knee extension in the gait cycle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 36 weeks after ACL reconstruction surgery.
the moment of knee extension in the gait cycle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
at 48 weeks after ACL reconstruction surgery.
Secondary Outcomes (3)
The International Knee Documentation Committee (IKDC) score
at 24 weeks after ACL reconstruction surgery.
The International Knee Documentation Committee (IKDC) score
at 36 weeks after ACL reconstruction surgery.
The International Knee Documentation Committee (IKDC) score
at 48 weeks after ACL reconstruction surgery.
Study Arms (3)
knee extension constraint rehabilitation group
OTHERplacebo group
OTHERcontrol group
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Patients who have isolated ACL injury and receive ACL reconstruction surgery at Sports Medicine Center, 3rd Hospital of Beijing University, Beijing, China.
- years old
- With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
- All participants have no known disorders or diseases other than ACL rupture.
You may not qualify if:
- Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hongshi Huang, Doctor
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Patients and investigator all don't know which group they participated in.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 9, 2020
Study Start
July 28, 2016
Primary Completion
December 30, 2020
Study Completion
December 31, 2021
Last Updated
July 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share