Passiv Continuous Patella Mobilisation
Conditions
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.
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.
Interventions
DEVICEPatello
The Patello is a new intervention device which mobilizes the Patella passively and continuously in cranial-caudal direction to increase Patella mobility.
Sponsors
University of Applied Sciences and Arts of Southern Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
The right knee is treated by the intervention device Patello
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patellofemoral Translation | Assessed after 1, 10, 20, 30 and 50 mobilization repetitions during a single continous passieve patellar moblizitaion session of 50 repetitions (total duration approximately 5-10 minutes) | Patellar cranial-caudal translation (in centimeters) is assessed repeatedly within a single passive continuous mobilization session. A total of 50 repetitions are performed at a constant mobilization speed. Ultrasound video sequences are recorded, and patellar translation is analyzed immediately after 1, 10, 20, 30, and 50 repetitions during the same session. |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Patello: The Patello is a new intervention device which mobilizes the Patella passively and continuously in cranial-caudal direction to increase Patella mobility. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Patello |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 36.0 years STANDARD_DEVIATION 10.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Switzerland | 9 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Patellofemoral Translation
Patellar cranial-caudal translation (in centimeters) is assessed repeatedly within a single passive continuous mobilization session. A total of 50 repetitions are performed at a constant mobilization speed. Ultrasound video sequences are recorded, and patellar translation is analyzed immediately after 1, 10, 20, 30, and 50 repetitions during the same session.
Time frame: Assessed after 1, 10, 20, 30 and 50 mobilization repetitions during a single continous passieve patellar moblizitaion session of 50 repetitions (total duration approximately 5-10 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patello | Patellofemoral Translation | 1 repetition | 0.819 cm | Standard Deviation 0.396 |
| Patello | Patellofemoral Translation | 10 repetitions | 0.734 cm | Standard Deviation 0.28 |
| Patello | Patellofemoral Translation | 20 repetitions | 0.776 cm | Standard Deviation 0.307 |
| Patello | Patellofemoral Translation | 30 rep. | 0.771 cm | Standard Deviation 0.3 |
| Patello | Patellofemoral Translation | 50 rep. | 0.774 cm | Standard Deviation 0.297 |