Effectiveness of Passive and Active ROM Exercises Following TKA

Not Applicable

Completed

• Conditions: Osteoarthritis; Total Knee Arthroplasty
• Interventions: Other: continuous passive motion (CPM); Other: controlled active motion (CAM I); Other: controlled active motion (CAM II)

• Registration Number: NCT02062138
• Lead Sponsor: University of Rostock

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-13
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous passive motion (CPM)	continuous passive motion (CPM)	-
controlled active motion (CAM I)	controlled active motion (CAM I)	-
controlled active motion (CAM II)	controlled active motion (CAM II)	-

Primary Outcome Measures

Name	Time	Method
range of motion	change from baseline (before surgery) to discharge (9 days post surgery)

Secondary Outcome Measures

Name	Time	Method
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	change from baseline (before surgery) to discharge (9 days after surgery)	stair climbing test, timed up and go test
cognitive functioning	change from baseline (before surgery) to discharge (9 days after surgery)
physical activity	change from baseline (before surgery) to discharge (9 days after surgery)	over a period of 7 days using the activPAL activity recording system.
pain	change from baseline (before surgery) to discharge (9 days after surgery)	visual analogue scale (VAS)
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	change from baseline (before surgery) to discharge (9 days after surgery)	36-item Short Form Health Survey (SF-36)

Trial Locations

Locations (1)

Department of Orthopedics, University Medicine Rostock; 🇩🇪 Rostock, Germany