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Clinical Trial NCT07089212 for Knee Arthroplasty, Total, Rehabilitation Therapy is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Combined Cyclic Compression Cryotherapy and Phased Rehabilitation Training for Recovery After Knee Replacement 100 Exercise-Based
Clinical Trial NCT07089212 is an interventional study for Knee Arthroplasty, Total, Rehabilitation Therapy that is active, not recruiting. It started on 23 April 2025 with plans to enroll 100 participants. Led by Qilu Hospital of Shandong University, it is expected to complete by 1 September 2025. The latest data from ClinicalTrials.gov was last updated on 28 July 2025.
Brief Summary
Total knee arthroplasty (TKA) is an effective treatment for severe knee joint diseases; however, postoperative complications such as pain, swelling, and delayed functional recovery remain common challenges. Cyclic compression cryotherapy, which applies alternating cold and pressure to the knee joint, can effectively reduce swelling and alleviate pain. Meanwhile, phased rehabilitation training, tailored to the specifi...Show More
Official Title
The Efficacy of Cyclic Compression Cryotherapy Combined With Phased Rehabilitation Training on Lower Limb Functional Recovery in Patients After Total Knee Arthroplasty
Conditions
Knee Arthroplasty, TotalRehabilitation TherapyOther Study IDs
- KYLL-202502-012-1
NCT ID Number
Start Date (Actual)
2025-04-23
Last Update Posted
2025-07-28
Completion Date (Estimated)
2025-09-01
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active Comparatorconventional rehabilitation treatment. The control group underwent a 12-week conventional rehabilitation program, which primarily included muscle strength training, endurance training, proprioception training, and joint range of motion (ROM) exercises. Assessments were conducted at baseline (before treatment), as well as at 2 weeks, 6 weeks, and 12 weeks post-treatment. The evaluated outcomes included knee joint ROM, muscle strength, knee function, pain l...Show More | Conventional rehabilitation treatment. The control group underwent a 12-week conventional rehabilitation program, which primarily included muscle strength training, endurance training, proprioception training, and joint range of motion (ROM) exercises. Assessments were conducted at baseline (before treatment), as well as at 2 weeks, 6 weeks, and 12 weeks post-treatment. The evaluated outcomes included knee joint ROM, muscle strength, knee function, pain l...Show More |
ExperimentalCyclic cryotherapy combined with staged rehabilitation treatment. The experimental group received cyclic compression cryotherapy combined with phased rehabilitation training in addition to the conventional rehabilitation program, with a total intervention duration of 12 weeks. | Phased Rehabilitation Training Rehabilitation is divided into three postoperative phases:
Early Phase (Weeks 1-2): Focus on edema control, quadriceps activation, and passive/active-assisted range of motion (ROM) exercises.
Intermediate Phase (Weeks 3-6): Progress to strength training, endurance exercises, and early proprioception drills.
Late Phase (Weeks 7-12): Advance to functional training , dynamic proprioception, and full ROM restoration. Cyclic Compression Cryotherapy Initiation: Begin within 24 hours postoperatively. Each session lasts 20-30 minutes, administered 2-3 times daily.
Procedure: Apply a cryotherapy wrap circumferentially around the knee using a pneumatic compression device, with precise control of pressure and temperature.
Pressure Settings: Start at Level I-II (low-to-moderate) and adjust incrementally based on patient tolerance.
Temperature Control: Maintain at 1...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Knee Function Scores | At 6 weeks after completion of treatment. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Range of Motion (ROM) | At 6 weeks after completion of treatment. | |
Muscle Strength | At 6 weeks after completion of treatment. | |
Activities of Daily Living (ADLs) | At 6 weeks after completion of treatment. | |
Visual Analog Scale (VAS) | At 6 weeks after completion of treatment. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Diagnosed with knee osteoarthritis (KOA) and within 12 weeks after total knee arthroplasty (TKA).
- Aged 18-70 years.
- First-time unilateral TKA (non-revision surgery).
- Physically and cognitively capable of completing required assessments.
- Able to fully adhere to the study protocol.
- Willing to participate in and complete the entire rehabilitation program.
- No contraindications for surgery or postoperative rehabilitation.
- Intact cognitive function (able to provide informed consent and follow instructions).
- Available for all follow-up evaluations.
1. Severe cardiovascular or cerebrovascular diseases. 2. Neuromuscular impairments affecting the lower limbs. 3. Concurrent hip or ankle joint disorders. 4. Intolerance to pain (unable to tolerate rehabilitation protocols). 5. Primary or metastatic bone tumors. 6. Rheumatoid arthritis (RA) or other systemic inflammatory arthropathies. 7. Severe obesity (BMI ≥35) or malnutrition (clinically diagnosed). 8. Inability to comply with study assessments (e.g., due to cognitive or physical limitations).
9. Visual dysfunction impairing task performance. 10. Functional impairment of the non-operated limb hindering testing/training. 11. Ankylosing spondylitis (AS). 12. History of allergic hypersensitivity to interventions used in the study. 13. Hemorrhagic predisposition (e.g., coagulation disorders, anticoagulant use).
14. Active tuberculosis or chronic myelitis. 15. History of substance dependence (e.g., opioids, alcohol). 16. Psychiatric disorders (e.g., schizophrenia, major depression). 17. Severe dysfunction of major organs (e.g., hepatic, renal, pulmonary).
Qilu Hospital of Shandong UniversityNo contact data.
1 Study Locations in 1 Countries
Shandong
107 Wenhua Xi Road, Ji'nan Shandong 250012, Jinan, Shandong, 250012, China