Anterior Cruciate Ligament InjuriesNCT04464902
The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction
A study testing brace1 and brace2 in people with Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- brace1 and brace2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2016to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Hongshi Huang, Doctor, 01082267565, huanghs@bjmu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- brace1, brace2, No Intervention
- Keywords
- anterior cruciate ligament, injury prevention, knee extension constraint
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brace1Device
The brace1 can provide resistance when patients want to extend their knee.
brace2Device
The brace1 can't provide resistance when patients want to extend their knee.
No InterventionOther
Control Group don't have any brace.
| Study group | Role | What they receive |
|---|---|---|
| knee extension constraint rehabilitation group | Other | Not described Receives: Device: brace1 |
| placebo group | Other | Not described Receives: Device: brace2 |
| control group | Other | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Measured: at 24 weeks after ACL reconstruction surgery.
walking speed
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Measured: at 36 weeks after ACL reconstruction surgery.
walking speed
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Measured: at 48 weeks after ACL reconstruction surgery.
ground reaction force
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Measured: at 24 weeks after ACL reconstruction surgery.
ground reaction force
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Measured: at 36 weeks after ACL reconstruction surgery.
ground reaction force
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Measured: at 48 weeks after ACL reconstruction surgery.
knee flexion angle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Measured: at 24 weeks after ACL reconstruction surgery.
knee flexion angle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Measured: at 36 weeks after ACL reconstruction surgery.
knee flexion angle
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 48 weeks after ACL reconstruction surgery.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at 48 weeks after ACL reconstruction surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start28 Jul 2016
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongshi Huang, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464902
- Sponsor's protocol ID
- IR001
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT04464902
- Acronym / sponsor ID
- IR001
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- anterior cruciate ligament, injury prevention, knee extension constraint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| knee extension constraint rehabilitation group | Other | Device: brace1 |
| placebo group | Other | Device: brace2 |
| control group | Other | Other: No Intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brace1The brace1 can provide resistance when patients want to extend their knee. | Device | knee extension constraint rehabilitation group |
| brace2The brace1 can't provide resistance when patients want to extend their knee. | Device | placebo group |
| No InterventionControl Group don't have any brace. | Other | control group |
Primary outcome
walking speed
Time frame: at 24 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
walking speed
Time frame: at 36 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
walking speed
Time frame: at 48 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
ground reaction force
Time frame: at 24 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
ground reaction force
Time frame: at 36 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
ground reaction force
Time frame: at 48 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
knee flexion angle
Time frame: at 24 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
knee flexion angle
Time frame: at 36 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
knee flexion angle
Time frame: at 48 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
the moment of knee extension in the gait cycle
Time frame: at 24 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
the moment of knee extension in the gait cycle
Time frame: at 36 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
the moment of knee extension in the gait cycle
Time frame: at 48 weeks after ACL reconstruction surgery.
Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
3 secondary outcomes
The International Knee Documentation Committee (IKDC) score
Time frame: at 24 weeks after ACL reconstruction surgery.
The International Knee Documentation Committee (IKDC) score
Time frame: at 36 weeks after ACL reconstruction surgery.
The International Knee Documentation Committee (IKDC) score
Time frame: at 48 weeks after ACL reconstruction surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongshi Huang, Doctor study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brace1 and brace2 in people with Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Yu, Bachler (+8615201134356, YYY1091012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking speed (time frame: at 24 weeks after ACL reconstruction surgery.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.