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

NCT04939389 | Completed

• 1 other identifier: MA-KNEE
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Status After Knee Surgery

Outcome Measures

Primary Outcomes (8)

• 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.

Interventions

Orthelligent Pro DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• crossklinik AG: lead
• Basel Academy for Quality and Research in Medicine: collaborator

Study Sites (1)

crossklinik AG

Basel, 4054, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36554461 RESULT

Study Officials

• Jennifer Eymann, MSc

  crossklinik AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Paired measurements with two different measurement methods

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 25, 2021
• Study Start: June 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: April 9, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available after publication of the study results

Locations

CH (1)