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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous passive motion (CPM) | Active Comparator |
| |
| controlled active motion (CAM I) | Experimental |
| |
| controlled active motion (CAM II) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous passive motion (CPM) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| range of motion | change from baseline (before surgery) to discharge (9 days post surgery) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Bader, MD | Department of Orthopedics, University Medicine Rostock | Study Chair |
| Ralf Skripitz, MD | Department of Orthopedics, University Medicine Rostock | Study Director |
| Anett Mau-Moeller, M.A. | Department of Orthopedics, University Medicine Rostock | Principal Investigator |
| Martin Behrens | Department of Kinesiology, University of Rostock | Principal Investigator |
| Tino Stöckel, PhD | Department of Kinesiology, University of Rostock | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedics, University Medicine Rostock | Rostock | 18057 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34239883 | Derived | Jacksteit R, Stockel T, Behrens M, Feldhege F, Bergschmidt P, Bader R, Mittelmeier W, Skripitz R, Mau-Moeller A. Low-Load Unilateral and Bilateral Resistance Training to Restore Lower Limb Function in the Early Rehabilitation After Total Knee Arthroplasty: A Randomized Active-Controlled Clinical Trial. Front Med (Lausanne). 2021 Jun 22;8:628021. doi: 10.3389/fmed.2021.628021. eCollection 2021. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015915 | Motion Therapy, Continuous Passive |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| controlled active motion (CAM I) | Other | Patients receive three 30 minutes CAM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge. |
|
| controlled active motion (CAM II) | Other | Patients receive three 30 minutes CAM applications (bilateral alternating) each day from the second postoperative day until 1 day prior to discharge. |
|
| 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) |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D026201 | Musculoskeletal Manipulations |