Prosthesis UserNCT04799145
Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee
A study testing Investigational device and Prescribed device in people with Prosthesis User and Amputation, run by Össur Iceland ehf.
Trial summary
This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on their prescribed knee as well as the investigational device at two separate visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis User, Amputation
- What is being tested?
- Investigational device and Prescribed device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2021to 24 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50Kg< body weight < 116Kg
- Cognitive ability to understand all instructions and questionnaires in the study;
- K1-K2 unilateral transfemoral amputees
- Allows for 37mm knee center height to dome of pyramid alignment
- Age ≥ 18 years
- Willing and able to participate in the study and follow the protocol
- Comfortable and stable socket fit (5 or over on the SFCS)
Who cannot join
- Users with cognitive impairment
- Users aged <18y
- Bilateral amputees
- Users with stump pain affecting their functional mobility
- Users with socket problems
- Users with co-morbidities in the contra-lateral limb, which significantly affect their functional mobility
About this study
Official title: Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With Mobili Knee (a Powered Microprocessor-controlled Knee Prosthesis)
This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on their prescribed knee as well as the investigational device at two separate visits. Performance was compared and statistically analyzed.
Read the detailed description
Participants were consented, and all tests were conducted at the Össur Motion lab Grjótháls 1-5, 110 Reykjavik.
There were two scheduled study events. At the initial visit, the first study event, for each subject a researcher qualified to obtain informed consent seated the subject and proceeded as described in chapter 13.7 Informed consent in [2].
Prior to fitting the subject was asked to provide feedback on their prescribed prosthesis, by filling in a questionnaire and perform AMPro, LCI (modified), TUG test, 2MWT and other validation activities (stand to sit, sit to stand, level ground, stair and ramp walking), as applicable. The users were fitted within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain.
After initial fitting subjects carried out validation tasks (stand to sit, sit to stand tasks, level ground walking at different speeds, stair and ramp walking), stroop test (cognitive loading) and FSST on the investigational device, after which they answered an in-house questionnaire to provide feedback.
During the second event, subjects were fitted with the investigational device and asked to perform the TUG, 2MWT and any validation tasks that could not be completed at visit 1 on the investigational device due to time restraints or subject condition.
If for some reason all tasks could not be completed at visit 1 and 2 due to time restraints or subject condition, a third visit was added.
Subjects did not wear the device home between visits.
Statistical Considerations:
Outcomes were inspected for normality. If the data was deemed to have a normal distribution the hypothesis was tested using a two-tailed, paired t-test (Only hypothesis A and B). If data was deemed non-normal that hypothesis was tested using a Wilcoxon signed rank test. Significance level (alpha) will be set at 0.05.
Other endpoints and acceptance criteria were assessed with descriptive statistics only.
- Conditions
- Prosthesis User, Amputation
- Being tested
- Investigational device, Prescribed device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational deviceDevice
Motorized microprocessor controlled prosthetic knee.
Prescribed deviceDevice
Passive microprocessor controlled knee and mechanical knee
| Study group | Role | What they receive |
|---|---|---|
| Investigational device | Experimental | All subjects performed outcome measures on their prescribed knee and the investigational device for comparison. Receives: Device: Investigational device; Device: Prescribed device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test (TUG Test)
Subjects are timed while completing a task of getting up from a chair, walking 3 meters at self-selected walking speed, turning around a cone and returning to sit down in the chair.Time is stopped from leaving the chair until the subject is sitting again. The time is measured in seconds. The faster the subject can complete the task the better. Results correlate with gait speed, balance, functional level, the ability to go out, and can follow change over time. It is assumed that subjects that take longer than 14s to complete the TUG might have a higher risk for falls.
Measured: 1 week
Secondary outcomes (1)
2 Minute Walk Test
Subjects walk at self-selected walking speed for 2 minutes, they shall walk as far as possible
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start5 Feb 2021
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prosthesis UserStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective case series design, within subject comparison
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799145
- Sponsor's protocol ID
- CII2020111613
- Status last verified
- Oct 2025
- First submitted
- 11 Mar 2021
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With Mobili Knee (a Powered Microprocessor-controlled Knee Prosthesis)
- ClinicalTrials.gov ID
- NCT04799145
- Acronym / sponsor ID
- CII2020111613
- Conditions
- Prosthesis User, Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on their prescribed knee as well as the investigational device at two separate visits. Performance was compared and statistically analyzed.
Detailed description
Participants were consented, and all tests were conducted at the Össur Motion lab Grjótháls 1-5, 110 Reykjavik.
There were two scheduled study events. At the initial visit, the first study event, for each subject a researcher qualified to obtain informed consent seated the subject and proceeded as described in chapter 13.7 Informed consent in [2].
Prior to fitting the subject was asked to provide feedback on their prescribed prosthesis, by filling in a questionnaire and perform AMPro, LCI (modified), TUG test, 2MWT and other validation activities (stand to sit, sit to stand, level ground, stair and ramp walking), as applicable. The users were fitted within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain.
After initial fitting subjects carried out validation tasks (stand to sit, sit to stand tasks, level ground walking at different speeds, stair and ramp walking), stroop test (cognitive loading) and FSST on the investigational device, after which they answered an in-house questionnaire to provide feedback.
During the second event, subjects were fitted with the investigational device and asked to perform the TUG, 2MWT and any validation tasks that could not be completed at visit 1 on the investigational device due to time restraints or subject condition.
If for some reason all tasks could not be completed at visit 1 and 2 due to time restraints or subject condition, a third visit was added.
Subjects did not wear the device home between visits.
Statistical Considerations:
Outcomes were inspected for normality. If the data was deemed to have a normal distribution the hypothesis was tested using a two-tailed, paired t-test (Only hypothesis A and B). If data was deemed non-normal that hypothesis was tested using a Wilcoxon signed rank test. Significance level (alpha) will be set at 0.05.
Other endpoints and acceptance criteria were assessed with descriptive statistics only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective case series design, within subject comparison
| Arm | Type | Receives |
|---|---|---|
| Investigational device | Experimental | Device: Investigational device, Device: Prescribed deviceAll subjects performed outcome measures on their prescribed knee and the investigational device for comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50Kg< body weight < 116Kg
- Cognitive ability to understand all instructions and questionnaires in the study;
- K1-K2 unilateral transfemoral amputees
- Allows for 37mm knee center height to dome of pyramid alignment
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- Users with cognitive impairment
- Users aged <18y
- Bilateral amputees
- Users with stump pain affecting their functional mobility
- Users with socket problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational deviceMotorized microprocessor controlled prosthetic knee. | Device | Investigational device |
| Prescribed devicePassive microprocessor controlled knee and mechanical knee | Device | Investigational device |
Primary outcome
Timed Up and Go Test (TUG Test)
Time frame: 1 week
Subjects are timed while completing a task of getting up from a chair, walking 3 meters at self-selected walking speed, turning around a cone and returning to sit down in the chair.Time is stopped from leaving the chair until the subject is sitting again. The time is measured in seconds. The faster the subject can complete the task the better. Results correlate with gait speed, balance, functional level, the ability to go out, and can follow change over time. It is assumed that subjects that take longer than 14s to complete the TUG might have a higher risk for falls.
1 secondary outcome
2 Minute Walk Test
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Prosthesis User
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Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device and Prescribed device in people with Prosthesis User and Amputation, run by Össur Iceland ehf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (TUG Test) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.