- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06894706
The Impact of Functional Exercise Training on Postoperative Knee Joint Recovery in Patients with Meniscal Injury
Lanzhou Anning District People's Hospital
AIM: To investigate the impact of functional exercise training on postoperative functional recovery in patients with knee meniscus injuries.
METHODS:A prospective randomized controlled trial (RCT) was conducted from April 2023 to September 2024, involving 96 patients with knee meniscus injuries who underwent meniscus repair interventions. Participants were randomly assigned to either the Control (CON) group (n=48) or the functional exercise training (FET) group (n=48) using a computer-generated random number table. The CON group received standard rehabilitation, while the FET group underwent functional exercise training. Clinical outcomes were evaluated at baseline, 1 month, and 6 months post-intervention, including the Lysholm score, IKDC score, VAS pain score, range of motion (ROM), serum levels of prostaglandin E2 (PGE2) and serotonin (5-HT), as well as passive 60° position sense and 60° motion sense. Postoperative complications occurring within 1 month were also recorded.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lanzhou, China
- Lanzhou Anning District People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- meniscus injury was diagnosed by magnetic resonance imaging; meniscoplasty was performed; No shedding occurred during follow-up.
Exclusion Criteria:
- Patients with joint dislocation and fracture; poor compliance; severe osteoarthritis, rheumatoid arthritis; Combined with metabolic diseases, coagulation disorders and serious organic diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Control (CON) group
Both groups were given arthroscopy and meniscoplasty.
After operation, the control group received active knee flexion and extension exercise, ankle pump training, quadriceps muscle training and other routine rehabilitation training.
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Both groups were given arthroscopy and meniscoplasty.
After operation, the control group received active knee flexion and extension exercise, ankle pump training, quadriceps muscle training and other routine rehabilitation training.
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Other: Functional exercise training (FET) group
Patients in the observation group were supplemented with neuromuscular training on the basis of routine rehabilitation training, and received rehabilitation education before training.
The patients were informed of the specific content, frequency, expected effect and importance of training in various forms such as on-site demonstration combined with publicity brochures and playing videos, so as to improve patient cooperation.
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Patients in the observation group were supplemented with neuromuscular training on the basis of routine rehabilitation training, and received rehabilitation education before training.
The patients were informed of the specific content, frequency, expected effect and importance of training in various forms such as on-site demonstration combined with publicity brochures and playing videos, so as to improve patient cooperation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Demographic data comparison
Time Frame: baseline, pre-intervention
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baseline, pre-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lysholm Knee Scoring Scale scores
Time Frame: up to 24 weeks
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The Lysholm Knee Scale (Lysholm Knee Scale) is a widely used assessment tool to measure the functional status and quality of life of the knee joint, especially in the assessment of recovery after knee injury and surgery.
The scale quantifies knee function through eight items (such as claudication, pain, stability, etc.), with a total score ranging from 0 to 100, with higher scores indicating better knee function.
The Lysholm Scale is designed to provide clinicians with an effective assessment tool to help them judge the impact of knee disease and injury.
The MCID is 10 points.
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up to 24 weeks
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International Society of Knee Injuries and Arthroscopy Score
Time Frame: up to 24 weeks
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IKDC (International Knee Injury and Arthroscopy Score) is a tool used to assess knee function and symptoms and is widely used in rehabilitation assessment of knee injuries, especially in recovery monitoring after anterior cruciate ligament and meniscus injuries.
The rating scale includes four main items: symptoms (pain, swelling, etc.), activity (functional limitations in daily activities), motor capacity (performance in physical activities), and function (knee stability and load-bearing capacity).
The IKDC score is scored on a scale of 0 to 100, with 0 indicating complete loss of knee function and 100 indicating complete recovery and normal function of the knee.
The higher the score, the better, indicating better knee function and less severe symptoms.
The MCID (minimum clinically significant difference) of IKDC is usually 10 points.
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up to 24 weeks
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Range of Motion
Time Frame: up to 24 weeks
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up to 24 weeks
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Visual Analog Scale
Time Frame: up to 24 weeks
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Visual analog scale (VAS) is a commonly used subjective pain assessment tool, which is widely used in clinical practice and research.
It is usually scored on a scale of 0 to 10, which is explained as follows: 0: completely painless.
1 to 3 points: mild pain, does not affect daily life.
Scores 4 to 6: Moderate pain that interferes with daily activities and sleep.
Score 7 to 10: Severe pain that severely affects quality of life and daily functioning.
MCID is usually 2 points.
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up to 24 weeks
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Passive position sense
Time Frame: up to 24 weeks
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The sensory threshold measurement method was used to measure passive position perception, motion perception and isotonic power.
During the passive 60° position perception test, subjects were asked to sit and stop when they felt reaching the target Angle with an eye mask and headset.
Each Angle was repeated three times.
Record the error between the target Angle and the measured Angle; 10% of the maximum contraction force of the quadriceps isometric resistance was selected, and the activity Angle of the knee joint was set as the activity degree of the knee joint in the seated position.
60 was measured on a CPM machine using a motion test sensor.
The subjects passively completed 60° knee flexion and extension at a constant angular speed of 1° / s.
The subjects stopped the movement when they felt the joint movement or the joint position change.
Three tests were conducted and the Angle of each perceived movement was recorded.
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up to 24 weeks
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Kinesthesia test
Time Frame: up to 24 weeks
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up to 24 weeks
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Prostaglandin E2
Time Frame: up to 24 weeks
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up to 24 weeks
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5-hydroxytryptamine
Time Frame: up to 24 weeks
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up to 24 weeks
|
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complications
Time Frame: up to 24 weeks
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The incidence of complications in the first month after operation was measured
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up to 24 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No. 20240927
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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