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The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
brace1
brace2
No Intervention
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring anterior cruciate ligament, injury prevention, knee extension constraint

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have isolated ACL injury and receive ACL reconstruction surgery at Sports Medicine Center, 3rd Hospital of Beijing University, Beijing, China.
  • 18-35 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.

Exclusion Criteria:

  • Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

knee extension constraint rehabilitation group

placebo group

control group

Arm Description

Outcomes

Primary Outcome Measures

walking speed
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
walking speed
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
walking speed
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
ground reaction force
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
ground reaction force
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
ground reaction force
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
knee flexion angle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
knee flexion angle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
knee flexion angle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
the moment of knee extension in the gait cycle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
the moment of knee extension in the gait cycle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
the moment of knee extension in the gait cycle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.

Secondary Outcome Measures

The International Knee Documentation Committee (IKDC) score
The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.
The International Knee Documentation Committee (IKDC) score
The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.
The International Knee Documentation Committee (IKDC) score
The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.

Full Information

First Posted
June 30, 2020
Last Updated
July 6, 2020
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04464902
Brief Title
The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction
Official Title
The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2016 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

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
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.
Detailed Description
Purpose Of exploring the biomechanical effect of knee extension constraint rehabilitation on rehabilitation after anterior cruciate ligament (ACL) reconstruction. Methods: Recruit 60 patients after ACL reconstruction. Divide them into three groups by random block method: Knee extension constraint rehabilitation group (wearing a brace with limitation of knee extension), Placebo group (wearing a brace without limitation of knee extension), and Control group (no brace is worn). The three groups of patients received the same rehabilitation training from 1 to 12 weeks after surgery, starting from week 13 and intervening on the first day of each week (wearing braces). Five tests were performed at the end of the 12th, 24th, 36th, and 48th weeks after surgery. Vicon system and force platform system will be synchronized used to test walking, jogging, side-cutting, and jumping; The Isokinetic dynamometer system will be used to test muscle strength. Outcome evaluation indicators and statistical methods: (1) Mixed design two-way analysis of variances will be used for the following indicators: approach run velocity and jump height; knee flexion angle at initial foot contact with the ground; knee extension moment at the time of peak impact poster ground reaction force, study group will be considered as an independent variable while testing time as the variable for repeated measurements. (2) The knee flexion, valgus-varus, and internal-external rotation angles, and extension, valgus-varus, and internal-external rotation moments of each leg during support phase of each movement will be expressed as functions of normalized movement time and leg (involved or uninvolved) using regression analysis with dummy variable. A dummy variable will be used to represent involved and uninvolved legs. A forward elimination procedure will be used to determine the best regression equations. The regression procedure will be stopped when the contributions of powers of n+1 and n+2 have no significant contribution to the overall regression. The contribution of the dummy variable in the regression will be an indication of asymmetry of the movements of involved and uninvolved legs. The effect of study group on movement asymmetry will be determined by comparing the contribution of dummy variables to the overall regression among study groups using a one-way ANOVA. The effects of study group and testing time on the ACL injury risk index will be determined for each knee in each movement using two-way ANOVA with mixed model. Study group will be considered as an independent variable while testing time as a repeated measure variable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
anterior cruciate ligament, injury prevention, knee extension constraint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Patients and investigator all don't know which group they participated in.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
knee extension constraint rehabilitation group
Arm Type
Other
Arm Title
placebo group
Arm Type
Other
Arm Title
control group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
brace1
Intervention Description
The brace1 can provide resistance when patients want to extend their knee.
Intervention Type
Device
Intervention Name(s)
brace2
Intervention Description
The brace1 can't provide resistance when patients want to extend their knee.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
Control Group don't have any brace.
Primary Outcome Measure Information:
Title
walking speed
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 24 weeks after ACL reconstruction surgery.
Title
walking speed
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 36 weeks after ACL reconstruction surgery.
Title
walking speed
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 48 weeks after ACL reconstruction surgery.
Title
ground reaction force
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 24 weeks after ACL reconstruction surgery.
Title
ground reaction force
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 36 weeks after ACL reconstruction surgery.
Title
ground reaction force
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 48 weeks after ACL reconstruction surgery.
Title
knee flexion angle
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 24 weeks after ACL reconstruction surgery.
Title
knee flexion angle
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 36 weeks after ACL reconstruction surgery.
Title
knee flexion angle
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 48 weeks after ACL reconstruction surgery.
Title
the moment of knee extension in the gait cycle
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 24 weeks after ACL reconstruction surgery.
Title
the moment of knee extension in the gait cycle
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 36 weeks after ACL reconstruction surgery.
Title
the moment of knee extension in the gait cycle
Description
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Time Frame
at 48 weeks after ACL reconstruction surgery.
Secondary Outcome Measure Information:
Title
The International Knee Documentation Committee (IKDC) score
Description
The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.
Time Frame
at 24 weeks after ACL reconstruction surgery.
Title
The International Knee Documentation Committee (IKDC) score
Description
The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.
Time Frame
at 36 weeks after ACL reconstruction surgery.
Title
The International Knee Documentation Committee (IKDC) score
Description
The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.
Time Frame
at 48 weeks after ACL reconstruction surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have isolated ACL injury and receive ACL reconstruction surgery at Sports Medicine Center, 3rd Hospital of Beijing University, Beijing, China. 18-35 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. Exclusion Criteria: Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyuan Yu, Bachler
Phone
+8615201134356
Email
YYY1091012@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongshi Huang, Doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongshi Huang, Doctor
Phone
01082267565
Email
huanghs@bjmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction

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