Amputation, Transfemoral Amputation
Conditions
Keywords
Microprocessor knee, prosthesis, powered prosthesis
Brief summary
The goal of this interventional study is to investigate a new firmware in development for Power Knee on gait and daily life activities in unilateral transfemoral amputees. The main question it aims to answer is: What are the effects of a new firmware on sit-to-stand, level walking and stair ascent ? Researchers will compare both a new and the current marketed firmware to see if there is any changes in performance. Participants will be asked to perform some activities of daily living and some functional tests.
Interventions
DEVICEPower Knee Firmware Update
The firmware in development will be uploaded to the device.
DEVICEPower Knee Current Marketed Firmware
The current marketed firmware will be uploaded to the device.
Sponsors
Össur Iceland ehf
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 50 kg \< body weight \< 116 kg * lower limb loss, amputation or deficiency * cognitive ability to understand all instructions and questionnaires in the study * Unilateral transfemoral amputees that are regular Power Knee users for at least 4 weeks * age ≥ 18 years * Moderate to high active subjects * Willing and able to participate in the study and follow the protocol * Comfortable and stable socket fit * No socket issues/changes in the last 6 weeks
Exclusion criteria
* Users with pain * Bilateral amputees * Users using passive microprocessor controlled knees * Users with cognitive impairment * Users with co-morbidities in the contra lateral limb, which affect their functional mobility * Hip disarticulation amputees * Users with osseointegrated prosthesis * Pregnant users
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sit to Stand Activity | after acclimatization at day 1 during the single study event | Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing sit to stand activity |
| Stand to Sit Activity | after acclimatization at day 1 during the single study event | Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stand to sit activity |
| Level Ground Walking | after acclimatization at day 1 during the single study event | Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing level ground walking. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPete Simpson
Össur Americas
Participant flow
Pre-assignment details
6 subjects with transfemoral amputation provided informed consent and were formally enrolled in the study, as reflected in the Protocol Section (6). However, one enrolled subject did not proceed to randomization due to low activity level and fatigue, and therefore did not start the intervention. As a result, only 5 participants were assigned to an Arm/Group and included in the Participant Flow module (5), and their data are presented in the Baseline Characteristics and analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 11.7 |
| Amputation level Transfemoral | 5 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
None listed