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Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement

Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement - A Prospective Randomized Controlled Multicenter Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06381752
Enrollment
175
Registered
2024-04-24
Start date
2019-06-25
Completion date
2020-03-31
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Keywords

CPM, inpatient rehabilitation, Staffelstein Score

Brief summary

Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes.

Detailed description

The aim of this study is to analyze the value (knee function, pain, and quality of life) of continuous passive motion (CPM) after total knee replacement (TKR), when it partially replaces group physiotherapy (PT) in inpatient rehabilitation to save human resources. Patients are randomized to CPM group, consisting of 3 daily sessions of 20 minutes each, or to group PT, consisting of 25 minutes physiotherapy in groups 5 days weekly. Multimodal rehabilitation does not differ for both groups throughout the 3-week rehabilitation stay. Primary outcome is the Staffelstein Score, German standard score in rehabilitation. Secondary outcomes are Oxford Knee Score (OKS), active and passive range of motion (ROM), and pain on visual analogue scale (VAS). Return to work is assessed by post-operative days.

Interventions

Daily application of continuous passive motion

OTHERstandard rehabilitation

standard rehabilitation program with group physiotherapy

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Total knee arthroplasty because of knee osteoarthritis * Inpatient rehabilitation in participating clinics

Exclusion criteria

* Pregnancy * Not able to give informed consent * Psychological disorders * Body weight > 150 kg * Hip range of motion < 50°

Design outcomes

Primary

MeasureTime frameDescription
Staffelstein Scorebaseline (t0) and 3 weeks later (t1)A maximum score of 120 points is possible including 3 sub dimensions with a maximum score of 40 points each. Sub dimensions consist of pain, activities of daily life (ADL), and ROM. The Staffelstein Score is assessed by a professional investigator. Higher scores indicated better results.

Secondary

MeasureTime frameDescription
Oxford Knee Score (OKS)baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2), 4 months after baseline (t3)Assessing patient's functional status. A maximum score of 48 points is possible including 12 questions with 0 - 4 points for each question \[12\]. Higher scores indicated better functional outcomes.
Range of motion (ROM)baseline (t0), 10 days after baseline (t1), 3 weeks after baselineRange of motion (ROM): Assessing the patient's knee range of motion with a mechanical goniometer
Visual Analogue Scale (VAS)baseline (t0), 10 days after baseline (t1), 3 weeks after baseline (t2)The patient rates pain during rest and during movement and draws a vertical line on a 10cm line with 0 cm indicating no pain and 10 cm indicating maximum pain
Return to workbaseline (t0), 4 months after baseline (t3)Assessed by post-operative days until first day of work

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026