NCT04799145

Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee

Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With Mobili Knee (a Powered Microprocessor-controlled Knee Prosthesis)

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Össur Iceland ehf · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Prosthesis User
• Amputation

Interventions

Type	Name	Description
DEVICE	Investigational device	Motorized microprocessor controlled prosthetic knee.
DEVICE	Prescribed device	Passive microprocessor controlled knee and mechanical knee

Timeline

• Start date: 2021-02-05
• Primary completion: 2021-02-24
• Completion: 2021-02-24
• First posted: 2021-03-16
• Last updated: 2026-01-21
• Results posted: 2026-01-21