Comparing a Sensor for Movement Assessment With Traditional Clinical Assessment Methods in Patients After Knee Surgery. (MA-KNEE)

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.

Study Overview

• Status: Completed
• Conditions: Status After Knee Surgery
• Intervention / Treatment: Diagnostic test: Orthelligent Pro

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4054
    • crossklinik AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 stretching	At 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 squat	At the single study visit directly after enrollment of the patient.
Angle reproduction when moving the lower leg to three randomly chosen angles	At 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 jump	At the single study visit directly after enrollment of the patient.
Number of jumps during 30s side hops	At the single study visit directly after enrollment of the patient.

Collaborators and Investigators

• Sponsor: crossklinik AG
• Collaborators: Basel Academy for Quality and Research in Medicine
• Investigators: Principal Investigator: Jennifer Eymann, MSc, crossklinik AG

Publications and helpful links

General Publications

• Eymann J, Vach W, Fischer L, Jakob M, Gosele A. Comparing a Sensor for Movement Assessment with Traditional Physiotherapeutic Assessment Methods in Patients after Knee Surgery-A Method Comparison and Reproducibility Study. Int J Environ Res Public Health. 2022 Dec 9;19(24):16581. doi: 10.3390/ijerph192416581.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: May 30, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MA-KNEE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available on request
• IPD Sharing Time Frame: The data will become available after publication of the study results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No