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Clinical Study to Assess the Effectiveness of the Device Patello (Patello)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512652
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Applied Sciences and Arts of Southern Switzerland

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Passiv Continuous Patella Mobilisation Device: Patello Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: One randomly selected knee is treated by the intervention device Patello
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Clinical Study to Assess the Effectiveness of the Device Patello
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : August 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Patello Device: Patello
The Patello is a new intervention device which mobilizes the Patella passively and continuously in cranial-caudal direction to increase Patella mobility.


Outcome Measures
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Primary Outcome Measures :
  1. Range of motion [ Time Frame: 1 hour ]
    The cranial-caudal mobilisation of the Patella is assessed during the mobilisation by means of the Patello.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512652


Locations
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Switzerland
SUPSI Landquart
Landquart, GR, Switzerland, 7302
Sponsors and Collaborators
University of Applied Sciences and Arts of Southern Switzerland
More Information
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Responsible Party: University of Applied Sciences and Arts of Southern Switzerland
ClinicalTrials.gov Identifier: NCT03512652    
Other Study ID Numbers: SUPSI
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No