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

NCT04799145 | Completed Results

• 1 other identifier: CII2020111613
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prosthesis User; Amputation

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Secondary Outcomes (1)

• 2 Minute Walk Test

  1 week

Study Arms (1)

Investigational device

EXPERIMENTAL

All subjects performed outcome measures on their prescribed knee and the investigational device for comparison.

Device: Investigational device; Device: Prescribed device

Interventions

Investigational device DEVICE

Motorized microprocessor controlled prosthetic knee.

Investigational device

Prescribed device DEVICE

Passive microprocessor controlled knee and mechanical knee

Investigational device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kg\< 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Össur Iceland ehf: lead

Results Point of Contact

• Title: Lisa Tronicke
• Organization: Össur ehf.

ltronicke@ossur.com

+4915155367970

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective case series design, within subject comparison

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: February 5, 2021
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share