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The Ideal Prosthesis Selection

The Ideal Prosthesis Selection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28616
Enrollment
29
Registered
2014-03-25
Start date
2014-04-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Persons with an upper leg amputation

Interventions

Part I: Participants will walk with five different prosthetic knees with varying biomechanical characteristics. The instantaneous effect of these prosthetic knees on the gait pattern will be determine

Sponsors

Research department of a rehabilitation centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Part I and III - Aged 18 or above - Unilateral transfemoral amputation or knee disarticulation - Functional level of K3 or K4 - At least one year after amputation Part II: - Aged 18 or above - Unilateral transfemoral amputation or knee disarticulation - Subject is expected to regain walking ability

Exclusion criteria

Exclusion criteria: - Other musculoskeletal problems influencing walking ability - Stump problems/bad socket fitting - Severe cognitive problems

Design outcomes

Primary

MeasureTime frame
Part I - Spatiotemporal variables such as stance/swing phase duration of double support phases. - Bilateral joint angle excursions of the hip, knee, and ankle. - Amount of energy produced and/or absorbed at the hip of the prosthetic leg and the joints of the intact leg. - Muscle activity patterns of muscles of both the stump and intact leg. - Energy cost of walking. Part II: - Spatiotemporal variables such as stance/swing phase duration of double support phases. - Bilateral joint angle excursions of the hip, knee, and ankle. - Prosthesis-related quality of life - Balance confidence - Performance-based measures of mobility. - Participation. Part III: Bilateral joint angle excursions

Secondary

MeasureTime frame
Part I: - Possible relationships between baseline and/or gait characteristics and the gait pattern while walking with different prosthesis. - Clinical applicability of a novel fully ambulatory gait analysis system.

Contacts

Public ContactErik Prinsen

Roessinghsbleekweg 33b

e.prinsen@rrd.nl+31 (0)53 4875761

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)