Functional mobility in patients with a unilateral transfemoral amputation: a comparison between the ReMotion Knee and polycentric mechanical knees currently used in healthcare.

Functional mobility in patients with a unilateral transfemoral amputation: a comparison between the ReMotion Knee and polycentric mechanical knees currently used in healthcare. - Mobility of transfemoral amputation patients: comparing prosthetic knees

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47968

Enrollment

Registered

2019-01-15

Start date

2019-02-27

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

above-knee amputation transfemoral amputatation

Interventions

Participants perform a set of functional measurements twice: once using the ReMotion Knee and once using their own prosthetic knee.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >18 - Unilateral transfemoral amputation or knee exarticulation - Activity level K2 or K3 - Time after amputation >1 year - ReMotion Knee can be connected to the participant*s own socket - Originally using a polycentric non-microprocessor controlled prosthetic knee - Written informed consent

Exclusion criteria

Exclusion criteria: - Complaints of pain of the residual stump. - Severe contractures affecting the hip range of motion - Other impairments that cause an increase in pain or a decrease in walking ability when standing and/or walking for thirty minutes - Weight >80 kg (weight limit of the ReMotion Knee is 80 kg) - Osseointegrated prosthesis (no socket)

Design outcomes

Primary

Measure	Time frame
The main study parameter is the difference in time (s) it takes the participant to finish the L-test between the two conditions. The test includes standing up and sitting down, twenty meters of straight walking and four turns, of which one is over the side of the prosthetic leg.	—

Secondary

Measure	Time frame
Secondary study parameters are gait quality, balance, precision stepping, performance of advanced walking tasks and patient experience. Gait quality is defined by walking speed, step length and %single limb support time. This will be measured using Intertial Measurement Units (IMUs) on the trunck and the feet. Balance is measured using the Berg Balance Score and the load distribution during static stance. Precision stepping will be measured using the Four Square Step Test. Advanced walking tasks are assessed using the EFAP, which combines a transfer (TUG), regular walking and advanced walking tasks. Finally, patient experience will be measured using an Numeric Rating Scale (NRS) to score the comfort, performance, fatigue and trust in balance using both proshtetic knees. After all the measurements, the participants are asked which prosthetic knee has their preference on each of these items.	—

Measure

Time frame

Secondary study parameters are gait quality, balance, precision stepping, performance of advanced walking tasks and patient experience. Gait quality is defined by walking speed, step length and %single limb support time. This will be measured using Intertial Measurement Units (IMUs) on the trunck and the feet. Balance is measured using the Berg Balance Score and the load distribution during static stance. Precision stepping will be measured using the Four Square Step Test. Advanced walking tasks are assessed using the EFAP, which combines a transfer (TUG), regular walking and advanced walking tasks. Finally, patient experience will be measured using an Numeric Rating Scale (NRS) to score the comfort, performance, fatigue and trust in balance using both proshtetic knees. After all the measurements, the participants are asked which prosthetic knee has their preference on each of these items.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)