Knee Injuries and DisordersNCT06674473
Evaluation of Long-term Isokinetic Training of Knee Joint
A study testing With robot assistance and traditional rehabilitation in people with Knee Injuries and Disorders, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to assess the effectiveness of isokinetic rehabilitation training under optimal stiffness in patients undergoing knee joint rehabilitation. The main questions it aims to answer are: Does isokinetic training under optimal stiffness lead to greater force exertion compared to… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Knee Injuries and Disorders
- What is being tested?
- With robot assistance and traditional rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2024to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-60 years.
- Patients with unilateral anterior cruciate ligament (ACL) rupture (with or without meniscus injury), posterior cruciate ligament (PCL) rupture, meniscal tear (M), and patellar dislocation (PD).
- 4. Postoperative period of 3-6 months. 5. No restriction in knee extension or flexion movements.
Who cannot join
- Patients with major diseases or conditions such as coronary heart disease, myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage, or malignant tumors.
- Pregnant or breastfeeding women and other special populations.
- Patients who refuse to sign the informed consent form or are unable to complete the entire study process.
- Patients currently infected with human immunodeficiency virus (HIV), or with a history of infectious hepatitis B or C.
- Patients with concurrent medical issues, including but not limited to: (1) Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥95 mmHg), congestive heart failure (New York Heart Association functional classification of stage III or IV). (2) Patients with mental incapacity or an inability to comprehend the study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100091
Yanggang Feng, Dr., 18811728786, yanggangfeng@buaa.edu.cn
About this study
Official title: Effect and Evaluation of Long-term Isokinetic Training of Knee Joint Under the Influence of Stiffness
The goal of this clinical trial is to assess the effectiveness of isokinetic rehabilitation training under optimal stiffness in patients undergoing knee joint rehabilitation. The main questions it aims to answer are:
- Does isokinetic training under optimal stiffness lead to greater force exertion compared to traditional bodyweight training?
- What are the long-term (6-week) effects of isokinetic training under optimal stiffness on joint flexibility and muscle strength? Researchers will compare the effects of isokinetic training under optimal stiffness to traditional bodyweight training to see if isokinetic training produces superior improvements in muscle strength, flexibility, and overall functional recovery.
Read more
Participants will:
- Perform regular training sessions using a portable knee joint isokinetic trainer, customized to their optimal stiffness for maximum force exertion.
- Engage in a 6-week rehabilitation program, with assessments at the beginning, and end of the study to evaluate changes in muscle strength, and functional recovery.
- Conditions
- Knee Injuries and Disorders
- Being tested
- With robot assistance, traditional rehabilitation
- Medical subject headings
- Knee Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With robot assistanceDevice
Use a portable isokinetic device
traditional rehabilitationBehavioural
Use traditional isotonic and isometric rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted Rehabilitation | Experimental | In this clinical trial, 6 patients who meet the inclusion criteria will be enrolled in the experimental group to undergo rehabilitation using a portable isokinetic device. Receives: Device: With robot assistance |
| None-robot-assisted Rehabilitation | Active comparator | The control group will consist of 6 patients who meet the inclusion criteria and will undergo traditional isotonic and isometric rehabilitation Receives: Behavioral: traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area of the quadriceps
Using MRI，Up to 6 weeks
Measured: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
Cross-sectional area of the hamstrings
using MRI， Up to 6 weeks
Measured: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
Peak flexion and extension knee torque
Using an integrated torque sensor
Measured: During each practice (6 weeks * 2 practices/week = 12 practices).
Average flexion and extension knee torque
Measured: During each practice (6 weeks * 2 practices/week = 12 practices).
Flexion and extension knee work
Work=Torque*Speed
Measured: In each ptractice (6 weeks * 2 practices /week = 12 practices).
Secondary outcomes (3)
Thigh circumference
10 cm proximal to the superior pole of the patella
Measured: In each ptractice (6 weeks * 2 practices /week = 12 practices).
Knee joint pain score (VAS score)
Up to 6 weeks，max. =100, min. =0, Visual Analogue Scale=VSA, A higher score indicates greater pain intensity.
Measured: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
Surface electromyography signals of quadricep and hamstrings
SEMG signals are used to evaluate the instant effect brought by the optimal stiffness.
Measured: During optimal stiffness measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start6 Nov 2024
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Injuries and DisordersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beihang University
- Responsible party
- Principal investigator, Yuan Fuzhen, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674473
- Sponsor's protocol ID
- 2024-492-05
- Status last verified
- Sep 2026
- First submitted
- 1 Nov 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Evaluation of Long-term Isokinetic Training of Knee Joint Under the Influence of Stiffness
- ClinicalTrials.gov ID
- NCT06674473
- Acronym / sponsor ID
- 2024-492-05
- Conditions
- Knee Injuries and Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beihang University
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 5 Nov 2024 (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.
The goal of this clinical trial is to assess the effectiveness of isokinetic rehabilitation training under optimal stiffness in patients undergoing knee joint rehabilitation. The main questions it aims to answer are:
- Does isokinetic training under optimal stiffness lead to greater force exertion compared to traditional bodyweight training?
- What are the long-term (6-week) effects of isokinetic training under optimal stiffness on joint flexibility and muscle strength? Researchers will compare the effects of isokinetic training under optimal stiffness to traditional bodyweight training to see if isokinetic training produces superior improvements in muscle strength, flexibility, and overall functional recovery.
Participants will:
- Perform regular training sessions using a portable knee joint isokinetic trainer, customized to their optimal stiffness for maximum force exertion.
- Engage in a 6-week rehabilitation program, with assessments at the beginning, and end of the study to evaluate changes in muscle strength, and functional recovery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted Rehabilitation | Experimental | Device: With robot assistanceIn this clinical trial, 6 patients who meet the inclusion criteria will be enrolled in the experimental group to undergo rehabilitation using a portable isokinetic device. |
| None-robot-assisted Rehabilitation | Active comparator | Behavioral: traditional rehabilitationThe control group will consist of 6 patients who meet the inclusion criteria and will undergo traditional isotonic and isometric rehabilitation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20-60 years.
- Patients with unilateral anterior cruciate ligament (ACL) rupture (with or without meniscus injury), posterior cruciate ligament (PCL) rupture, meniscal tear (M), and patellar dislocation (PD).
- 4. Postoperative period of 3-6 months. 5. No restriction in knee extension or flexion movements.
Key exclusion criteria (5 listed)
- Patients with major diseases or conditions such as coronary heart disease, myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage, or malignant tumors.
- Pregnant or breastfeeding women and other special populations.
- Patients who refuse to sign the informed consent form or are unable to complete the entire study process.
- Patients currently infected with human immunodeficiency virus (HIV), or with a history of infectious hepatitis B or C.
- Patients with concurrent medical issues, including but not limited to: (1) Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥95 mmHg), congestive heart failure (New York Heart Association functional classification of stage III or IV). (2) Patients with mental incapacity or an inability to comprehend the study requirements.
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 |
|---|---|---|
| With robot assistanceUse a portable isokinetic device | Device | Robot-assisted Rehabilitation |
| traditional rehabilitationUse traditional isotonic and isometric rehabilitation | Behavioural | None-robot-assisted Rehabilitation |
Primary outcome
Cross-sectional area of the quadriceps
Time frame: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
Using MRI，Up to 6 weeks
Cross-sectional area of the hamstrings
Time frame: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
using MRI， Up to 6 weeks
Peak flexion and extension knee torque
Time frame: During each practice (6 weeks * 2 practices/week = 12 practices).
Using an integrated torque sensor
Average flexion and extension knee torque
Time frame: During each practice (6 weeks * 2 practices/week = 12 practices).
Flexion and extension knee work
Time frame: In each ptractice (6 weeks * 2 practices /week = 12 practices).
Work=Torque*Speed
3 secondary outcomes
Thigh circumference
Time frame: In each ptractice (6 weeks * 2 practices /week = 12 practices).
Knee joint pain score (VAS score)
Time frame: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
Surface electromyography signals of quadricep and hamstrings
Time frame: During optimal stiffness measurements
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With robot assistance and traditional rehabilitation in people with Knee Injuries and Disorders, 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuanzhen Yuan, Dr. (+8618811728786, yanggangfeng@buaa.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional area of the quadriceps (time frame: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)). The study lists 5 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 15 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.