Clinical Study to Assess the Effectiveness of the Device Patello

NCT ID: NCT03512652

Last Updated: 2025-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2019-08-31

Brief Summary

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The device "Patello" was designed to passively mobilize the Patella in cranial-caudal direction. Its application field lays in the rehabilitation of any knee pathology where knee range of motion may be restricted due to the Patella mobility.

Detailed Description

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The effectiveness of the device Patello has not been tested so far. This clinical study aims to assess and proof the effectiveness of this device. The aim is to objectify the movement of the Patella induced by the device Patello in cranial / caudal direction. As outcome parameter serve ultrasound measurements of a bony reference point of the femur and the Patella and its displacement / distance after mobilization.

Conditions

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Passiv Continuous Patella Mobilisation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The right knee is treated by the intervention device Patello
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Patello

The participants' right knee was placed inside the patello device, a total of 50 repetitions, with a constant mobilisation speed, was conducted and the degree of translation was assessed after 1, 10, 20, 30 and 50 repetitions.

Group Type EXPERIMENTAL

Patello

Intervention Type DEVICE

The Patello is a new intervention device which mobilizes the Patella passively and continuously in cranial-caudal direction to increase Patella mobility.

Interventions

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Patello

The Patello is a new intervention device which mobilizes the Patella passively and continuously in cranial-caudal direction to increase Patella mobility.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* no operation and / or actual problems (pain at rest or during strain) of the muscular or bony parts of the lower extremities
* closed and intact skin conditions in the area of the knees and thighs
* no fear of the intervention
* willingness to participate on all 2 measurement days

Exclusion Criteria

* operation and / or actual problems (pain at rest or during strain) of the muscular or bony parts of the lower extremities
* open skin conditions in the area of the knees and thighs
* fear of the intervention
* no willingness to participate on all 2 measurement days
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Applied Sciences and Arts of Southern Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Clijsen, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Applied Sciences and Art of Switzerland (SUPSI)

Locations

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SUPSI Landquart

Landquart, Kanton Graubünden, Switzerland

Site Status

Countries

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Switzerland

References

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Hohenauer, E., Stoop, R., Koller, A., Gredig, J., Fenzl, M., Deflorin, C., & Clijsen, R. (2020). Efficacy of a new device for passive continuous patellar mobilization. International Journal of Medical and Biomedical Studies, 4(3), 07-10. doi: 10.32553/ijmbs.v4i3.971

Reference Type RESULT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Study Documents

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Document Type: scientific Article

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Related Links

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Other Identifiers

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SUPSI

Identifier Type: -

Identifier Source: org_study_id

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