The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction

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.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Device: brace1; Device: brace2; Other: No Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuanyuan Yu, Bachler; Phone Number: +8615201134356; Email: YYY1091012@126.com

Study Locations

• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
    • Contact: Hongshi Huang, Doctor; Phone Number: 01082267565; Email: huanghs@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group	Other: No Intervention; Control Group don't have any brace.
Other: knee extension constraint rehabilitation group	Device: brace1; The brace1 can provide resistance when patients want to extend their knee.
Other: placebo group	Device: brace2; The brace1 can't provide resistance when patients want to extend their knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 24 weeks after ACL reconstruction surgery.
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.	at 36 weeks after ACL reconstruction surgery.
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.	at 48 weeks after ACL reconstruction surgery.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2016
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: injury prevention; anterior cruciate ligament; knee extension constraint
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: IR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No