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Comparing a Sensor for Movement Assessment With Traditional Clinical Assessment Methods in Patients After Knee Surgery.

Comparing a Sensor for Movement Assessment With Traditional Clinical Assessment Methods in Patients After Knee Surgery.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04939389
Acronym
MA-KNEE
Enrollment
36
Registered
2021-06-25
Start date
2021-06-01
Completion date
2022-05-31
Last updated
2024-04-09

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

Conditions

Status After Knee Surgery

Brief summary

Eight parameters measurable by the sensor Orthelligent Pro are compared with traditional measurements based on a goniometer or video taping. The aim is to inform potential users about the distribution of the differences they have to expect when moving from traditional measurement methods to the new sensor. Patients will perform eight corresponding movement exercises at a single study visit.

Detailed description

In patients suffering from musculo-skeletal disorders, the restoration of full functioning is an important goal of many interventions. Assessment of functioning is often based on corresponding tests. If functioning is related to specific movement patterns, accelerometers and similar sensors are promising to allow a simple and objective assessment, and may replace traditional assessment methods, e.g. based on measurements with the goniometer. Corresponding products tend to enter the market and face clinicians and patients with the question, to which degree they are reliable and comparable with the traditional assessment methods. Recently, a sensor named Orthelligent Pro has been released by the medical device company OPED and is today commercially available. The sensor - to be attached to the knee of a subject - offers the opportunity to assess several parameters related to movement patterns in the lower extremities that are of relevance in the rehabilitation process of orthopedic patients. The aim of the current project is to inform potential users of this sensor about the difference they have to expect when compared to traditional assessment techniques of the same parameters and about the reproducibility of the measurements both based on the sensor and based on traditional assessments. Patients of a single clinic will be offered participation. The patients will perform the eight exercises at a single study visit arranged as an addition to a routine follow up visit.

Interventions

DIAGNOSTIC_TESTOrthelligent Pro

The sensor is attached to the knee of the participant and eight different movement exercises are performed

Sponsors

Basel Academy for Quality and Research in Medicine
CollaboratorUNKNOWN
crossklinik AG
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Paired measurements with two different measurement methods

Eligibility

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

Inclusion criteria

* Patients after knee surgery (ACL reconstruction, total or partial knee arthroplasty, knee arthroscopy etc.) who are scheduled to a clinical follow up assessment by the surgeon between 4 months and 15 months after surgery. * Informed consent

Exclusion criteria

* Age below 18 years * Patients who underwent surgery in the lower extremities within the last 4 months * Patients with severe acute pain * Patients with contraindications to perform the movements/exercises * Patients who underwent surgery also at the contralateral leg since the surgery related to the current follow up visit * Patients who cannot follow the instructions due to language or cognitive problems

Design outcomes

Primary

MeasureTime frame
Number of jumps during 30s side hopsAt the single study visit directly after enrollment of the patient.
Tilt angle of the leg in degrees during passive movement of the leg (knee joint)At the single study visit directly after enrollment of the patient.
Tilt angle of the leg in degrees during active movement of the leg (knee joint)At the single study visit directly after enrollment of the patient.
Tilt angle of the leg in degrees during leg stretchingAt the single study visit directly after enrollment of the patient.
Inward tilt of the lower leg in degrees/on an ordinal assessment scale during one-legged squatAt the single study visit directly after enrollment of the patient.
Angle reproduction when moving the lower leg to three randomly chosen anglesAt the single study visit directly after enrollment of the patient.
Jump height at vertical jump (on one leg)At the single study visit directly after enrollment of the patient.
Inward tilt of the lower leg in degrees/on an ordinal assessment scale at drop jumpAt the single study visit directly after enrollment of the patient.

Countries

Switzerland

Outcome results

None listed

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