A study protocol for objectively measuring knee recovery after anterior cruciate ligament reconstruction surgery: a biomechanical assessment technique
| ISRCTN | ISRCTN31723656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31723656 |
| Secondary identifying numbers | Research Project of Hunan Provincial Sports Bureau: 2024KT0188 |
- Submission date
- 19/04/2025
- Registration date
- 29/04/2025
- Last edited
- 28/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Knee function assessment plays a pivotal role in the management and rehabilitation of patients with anterior cruciate ligament (ACL) injuries, but knee function assessment primarily relies on clinical rating scales, and their reliability is often compromised by inter-individual variability, assessor subjectivity, and dependence on clinical experience. This study protocol aims to explore the application of mechanical quantitative techniques in the postoperative rehabilitation assessment following anterior cruciate ligament reconstruction (ACLR).
Who can participate?
Adult patients with unilateral leg ACL injury, arthroscopic autologous hamstring or patellar tendon ACL reconstruction surgery, with no other ligamentous injuries involved
What does the study involve?
This study involves an objective mechanical quantitative technology evaluation of knee muscle tension in patients after ACLR surgery.
What are the possible benefits and risks of participating?
Objective and quantitative evaluation results of the knee joint can be obtained by participating in this study, and since there are no other intervention means, it is believed that there is no potential risk in this study.
Where is the study run from?
Hunan Provincial Rehabilitation Hospital, China
When is the study starting and how long is it expected to run for?
October 2024 to April 2025
Who is funding the study?
The Research Project of the Hunan Provincial Sports Bureau, China
Who is the main contact?
Dr Zhichun Zhu, lagged@126.com
Contact information
Public, Scientific, Principal Investigator
No. 31, Yuhua lane, Yuhua District
Changsha City, Hunan Province
410021
China
 ORCID ID |
0000-0001-9322-1491 |
|---|---|
| Phone | +86 13548592933 |
| lagged@126.com |
Study information
| Study design | Cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Application of mechanical quantitative techniques in postoperative rehabilitation assessment of anterior cruciate ligament reconstruction: a study protocol |
| Study objectives | This study protocol aims to explore the application of mechanical quantitative techniques in the postoperative rehabilitation assessment following anterior cruciate ligament reconstruction (ACLR). ACL injuries are prevalent among athletes and pose a considerable threat to their careers. While ACLR remains the primary therapeutic intervention for such injuries, the assessment of postoperative rehabilitation still encounters significant challenges. Traditional assessment methods are limited by subjectivity and the absence of quantitative data. Mechanical quantitative techniques present a novel approach, offering objective and precise quantitative metrics for knee functional rehabilitation through the analysis of soft tissue mechanical properties. |
| Ethics approval(s) |
Approved 10/10/2024, Ethics Committee of Hunan Provincial Rehabilitation Hospital (No. 31, Yuhua lane, Yuhua District, Changsha City, Hunan Province, 410021, China; -; 524352104@qq.com), ref: - |
| Health condition(s) or problem(s) studied | Quantitative assessment for muscle tension of the knee after ACLR |
| Intervention | BRIEF NAME: Mechanical Quantitative Techniques. WHY: This study protocol aims to explore the application of mechanical quantitative techniques in the postoperative rehabilitation assessment following anterior cruciate ligament reconstruction (ACLR) and provide a scientific measurement tool for muscle tension. WHAT: Use of a musculoskeletal mechanical quantitative detector (M5) to measure the mechanical quantitative characteristics (shear modulus G) of the subject's rectus femoris and hamstring muscles. And the information about the materials can be found at:https://mp.weixin.qq.com/s/rJmYn8Yu-IFONFiqFXOIfQ. PROCEDURES: Firstly, clinical data will be collected from patients with anterior cruciate ligament injury to ensure sample diversity and representativeness. Secondly, quantitative measuring equipment is used to measure the knee joint and obtain relevant parameters. Strictly follow the operating procedures to ensure accurate and reliable data. Then, traditional rehabilitation assessment is conducted. Combining biomechanical methods, conducting in-depth data analysis to reveal the quantitative correlation between the degree of knee joint functional recovery and rehabilitation assessment results. Finally, a new clinical evaluation method is proposed and validated through evaluation. WHO PROVIDED: a. Doctors: Major in rehabilitation medicine, with more than 10 years of working experience, and received training in medical statistics and ultrasonic testing. b. physiotherapist: Major in rehabilitation therapy technology, with more than 5 years' working experience, and received relevant training on knee joint function, sports injury rehabilitation. HOW: The invention is supposed to be delivered face-to-face and will be provided individually. WHERE: The inventions will occur at the hospital WHEN AND HOW MUCH: For this research, all participants will be assessed 2 times, and the interval between the two assessments is supposed to be 12- 14 weeks. TAILORING: This research is an observational study with no tailoring or modifications. |
| Intervention type | Not Specified |
| Primary outcome measure | Shear modulus of the knee muscle measured using Mechanical Quantitative Techniques at the beginning of the study (t2) and 12- 14 weeks after t2 (t4) |
| Secondary outcome measures | The range of knee motion, knee muscle strength, and knee function measured using traditional assessment methods and theLysholm Knee Scoring Scale at the beginning of the study (t2) and 12- 14 weeks after t2 (t4) |
| Overall study start date | 10/10/2024 |
| Completion date | 05/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 66 |
| Total final enrolment | 72 |
| Key inclusion criteria | 1. Unilateral leg ACL injury, arthroscopic autologous hamstring or patellar tendon ACL reconstruction surgery, with no other ligamentous injuries involved 2. Swelling of the affected knee joint is grade 0 or 1+ 3. Time from injury to surgery is less than 2 months 4. Ages between 18 and 60 years 5. Sign an informed consent form for rehabilitation treatment and actively cooperate with the treatment 6. The treatment plan is approved by the Ethics Committee of the Hunan Provincial Rehabilitation Hospital |
| Key exclusion criteria | 1. Concurrent posterior cruciate ligament rupture or meniscal repair 2. Concurrent postoperative complications affecting limb exercise 3. Patients with a history of hip joint trauma 4. Individuals with hypertension, diabetes, or other chronic diseases of organs 5. Individuals with concurrent severe diseases of the heart, brain, kidneys, and hematopoietic system, and patients with mental illnesses 6. Concurrent with any conditions that are detrimental to patient recovery or continuation of the trial |
| Date of first enrolment | 05/04/2025 |
| Date of final enrolment | 05/10/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Changsha City, Hunan Province
410021
China
Sponsor information
Research organisation
No. 36, TIYU Road
Changsha, Hunan
410000
China
| Phone | +86 0731-84537955 |
|---|---|
| 155233269@qq.com | |
| Website | https://tyj.hunan.gov.cn/ |
"ROR" |
https://ror.org/01351nn19 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 05/06/0205 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (other) | 08/04/2025 | 22/04/2025 | No | No | |
| Statistical Analysis Plan | 28/04/2025 | No | No |
Additional files
Editorial Notes
22/04/2025: Study's existence confirmed by the Hunan Provincial Sports Bureau, China.
