Clinical Study to Assess the Effectiveness of the Device Patello (Patello)
September 18, 2019 updated by: University of Applied Sciences and Arts of Southern Switzerland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
GR
-
Landquart, GR, Switzerland, 7302
- SUPSI Landquart
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patello
|
The Patello is a new intervention device which mobilizes the Patella passively and continuously in cranial-caudal direction to increase Patella mobility.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion
Time Frame: 1 hour
|
The cranial-caudal mobilisation of the Patella is assessed during the mobilisation by means of the Patello.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2018
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
August 31, 2019
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
April 18, 2018
First Posted (Actual)
May 1, 2018
Study Record Updates
Last Update Posted (Actual)
September 20, 2019
Last Update Submitted That Met QC Criteria
September 18, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- SUPSI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.