The Ideal Prosthesis Selection

The Ideal Prosthesis Selection - TIPS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40432

Enrollment

Registered

2014-04-29

Start date

2014-08-14

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Amputation

Interventions

Part 1a Participants will walk with prosthetic knee from the following five categories for a short period of time. The categories are: - Constant resistance against flexion/extension and servo-assist

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Part I and III - Aged 18 or above - Unilateral transfemoral amputation or knee disarticulation - Functional level from K3 to K4 - At least one year after amputation;Part II: - Aged 18 or above - First 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

Measure	Time frame
Part 1a - 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 1b - 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 - Prosthesis-related quality of life - Balance confidence - Performance-based measures of mobility Part 2 - 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 - Prosthesis-related quality of life - Balance confidence - Performance-based measures of mobility Part 3 Inter- and intrasession variability of gait	—

Measure

Time frame

Part 1a - 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 1b - 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 - Prosthesis-related quality of life - Balance confidence - Performance-based measures of mobility Part 2 - 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 - Prosthesis-related quality of life - Balance confidence - Performance-based measures of mobility Part 3 Inter- and intrasession variability of gait

—

Secondary

Measure	Time frame
Part 1 - Relationships between baseline characteristics and the effect of the prosthetic knee on the gait pattern - Clinical applicability of a new fully ambulant gait analysis measurement system Part 2 Not relevant Part 3 Not relevant	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)