Trial Outcomes & Findings for Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee (NCT NCT04799145)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

6 participants

Primary outcome timeframe

1 week

Results posted on

2026-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All subjects performed outcome measures on their prescribed knee and the Mobili Knee investigational device for comparison. Power Knee Mainstream - Balance / Mobili Knee: Motorized microprocessor controlled prosthetic knee. Prescribed device: Passive microprocessor controlled knee and mechanical knee
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=6 Participants All subjects performed outcome measures on their prescribed knee and the investigational device for comparison. investigational device: Motorized microprocessor controlled prosthetic knee. Prescribed device: Passive microprocessor controlled knee and mechanical knee
Age, Continuous	63 years STANDARD_DEVIATION 4 • n=6 Participants
Sex: Female, Male Female	0 Participants n=6 Participants
Sex: Female, Male Male	6 Participants n=6 Participants
Region of Enrollment Iceland	6 participants n=6 Participants
Ampro	33 Total Score STANDARD_DEVIATION 6 • n=6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=6 Participants All subjects performed outcome measures on their prescribed knee and the investigational device for comparison. Investigational Device: Motorized microprocessor controlled prosthetic knee. Prescribed device: Passive microprocessor controlled knee and mechanical knee
Timed Up and Go Test (TUG Test) Prescribed prosthesis	13.3 seconds Standard Deviation 4.9
Timed Up and Go Test (TUG Test) Power Knee	16.8 seconds Standard Deviation 4.5

SECONDARY outcome

Timeframe: 1 week

Subjects walk at self-selected walking speed for 2 minutes, they shall walk as far as possible

Outcome measures

Outcome measures
Measure	All Participants n=6 Participants All subjects performed outcome measures on their prescribed knee and the investigational device for comparison. Investigational Device: Motorized microprocessor controlled prosthetic knee. Prescribed device: Passive microprocessor controlled knee and mechanical knee
2 Minute Walk Test Prescribed prosthesis	108.7 meters Standard Deviation 36.7
2 Minute Walk Test Power Knee	102.1 meters Standard Deviation 17.9

Adverse Events

Investigational Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Tronicke

Össur ehf.

Phone: +4915155367970

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place