Effectiveness of Passive and Active ROM Exercises Following TKA

Study Overview
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Brief Summary
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The purpose of the study is to determine the effectiveness of new interventional approaches in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that active training programs are more effective in improving physical function than the passive standard-of-care therapy.

Detailed Description
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The major objectives of rehabilitation after TKA are the early regain of range of motion (ROM) and mobilization of the patient. Continuous passive motion (CPM) is frequently used as part of the postoperative care regime following TKA with the aim to increase knee joint mobility and improve postoperative recovery despite little conclusive scientific evidence. Conflicting research findings have generated an ongoing debate on its usage. As the greatest loss of function occurs in the first month following TKA, it is surprising that the ROM therapy during hospital stay is still carried out passively. A passive mobilization of the knee joint with CPM does not encourage the patients to actively participate in their rehabilitation. Research on the effectiveness of active ROM exercises added to standard physiotherapy during the short in-hospital period is lacking so far.The objective of this study is to compare the passive clinical standard therapy (CPM) with different active training programs (controlled active motion, CAM). It was hypothesised that the CAM therapies are more effective in improving physical function than the CPM therapy.

Official Title
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Effectiveness of New Interventional Approaches to Improve Physical Function Following Total Knee Arthroplasty

Conditions
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Osteoarthritis, Total Knee Arthroplasty

Intervention / Treatment
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* Other: continuous passive motion (CPM)
* Other: controlled active motion (CAM I)
* Other: controlled active motion (CAM II)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with knee osteoarthritis and scheduled for primary TKA age: 50-80 Exclusion Criteria: BMI > 40 musculoskeletal and neurological disorders that limit physical function any planned further joint surgery within 6 months substantial pain or functional limitation which make the patients unable to perform study procedures

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continuous passive motion (CPM)<br> | Other: continuous passive motion (CPM)<br>* standard-of-care therapy (control intervention); Patients receive three 30 minutes CPM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.<br>|
| Experimental: controlled active motion (CAM I)<br> | Other: controlled active motion (CAM I)<br>* Patients receive three 30 minutes CAM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.<br>|
| Experimental: controlled active motion (CAM II)<br> | Other: controlled active motion (CAM II)<br>* Patients receive three 30 minutes CAM applications (bilateral alternating) each day from the second postoperative day until 1 day prior to discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motion |  | change from baseline (before surgery) to discharge (9 days post surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuromuscular function |  | change from baseline (before surgery) to discharge (9 days after surgery) | 
| joint position sense |  | change from baseline (before surgery) to discharge (9 days after surgery) | 
| motor function | stair climbing test, timed up and go test | change from baseline (before surgery) to discharge (9 days after surgery) | 
| cognitive functioning |  | change from baseline (before surgery) to discharge (9 days after surgery) | 
| physical activity | over a period of 7 days using the activPAL activity recording system. | change from baseline (before surgery) to discharge (9 days after surgery) | 
| pain | visual analogue scale (VAS) | change from baseline (before surgery) to discharge (9 days after surgery) | 
| swelling |  | change from baseline (before surgery) to discharge (9 days after surgery) | 
| length of hospital stay |  | change from baseline (before surgery) to discharge (9 days after surgery) | 
| quality of life | 36-item Short Form Health Survey (SF-36) | change from baseline (before surgery) to discharge (9 days after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, total knee arthroplasty, range of motion, continuous passive motion, controlled active motion, postoperative physical therapy