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The Ideal Prosthesis Selection


- candidate number17008
- NTR NumberNTR4478
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mrt-2014
- Secondary IDsNL.47202.044.13 
- Public TitleThe Ideal Prosthesis Selection
- Scientific TitleThe Ideal Prosthesis Selection
- ACRONYMTIPS
- hypothesisPart 1: Quantification of individual patient-prosthesis interactions - Determination of the instantaneous effect of prosthetic knees with variable biomechanical properties on the gait pattern of persons with an upper leg amputation (Part Ia). - Determination of the influence of the Total Knee versus an adaptive prosthesis on the gait pattern of persons with an upper leg amputation based on the relation between the individual needs of the persons with an upper leg amputation and the proposed function of these prosthetic knees (Part Ib). Part 2: Restoration of walking ability within the first year after amputation Exploration of the natural restoration of walking ability of persons with an upper leg amputation within the first year after amputation. Part 3: Inter- and intrasession variability of gait Determination of the inter- and intrasession variability of gait of persons with an upper leg amputation.
- Healt Condition(s) or Problem(s) studiedUpper leg amputation
- Inclusion criteriaPart 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- Other musculoskeletal problems influencing walking ability - Stump problems/bad socket fitting - Severe cognitive problems
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-apr-2014
- planned closingdate31-mrt-2016
- Target number of participants29
- InterventionsPart 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 determined. Next to this the longitudinal effect of two prosthetic knees on the gait pattern will be determined. Part II and III No intervention. These parts are strictly observational.
- Primary outcomePart 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 outcomePart 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.
- TimepointsPart I: Measurements will take place directly after prosthetic fitting (instantaneous effect) and after four weeks (longitudinal effect). Part II: Measurements will take place two weeks after prescription of provisional prosthesis, two weeks after provision of prosthesis and at the end of the treatment in the outward department. Part III: No specific endpoints.
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Erik Prinsen
- CONTACT for SCIENTIFIC QUERIES Erik Prinsen
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryNumerous factors are taken into account when prescribing prostheses. First of all, the physiatrist will try to determine what the (potential) activity level is or will be. In addition, preferences of the patient are taken into account. Thirdly, external factors may be of influence, for instance the policy of the insurance company of the patient. Finally, scientific evidence regarding the influence of a prosthesis on the walking pattern should be taken into account. When looking in the literature with respect to which prosthesis should be prescribed for which patient, a limited amount of studies are available. Based on this, the CBO guideline 'Amputation and prosthetics of the lower extremity' states that 'what type of prosthesis for which type of patient' is one of the essential research questions for the foreseeable future. In recent years, the added functionality of different prostheses has been increasingly studied. However, usually overall results are presented and relationships between the effect of the prosthetic knee and individual characteristics are scarcely studied. Because of this, it is unknown which type of patient benefited the most of the studied prosthetic knee. Next to this, previous research almost exclusively focused on patients with a stable gait pattern (usually one year after amputation is used as an inclusion criteria). Because of this, little is known about the restoration of walking ability. Knowledge of this is essential for the determination of the potential functional activity level of the patient. Finally, little is known about how the gait pattern of patients with an amputation can be reliably quantified. Usually 10-15 steps are collected and averaged and it is assumed that these steps are representative of the gait pattern. The TIPS project aims to gain insight into the added functionality of different prosthetic knees and the restoration of the gait pattern, taken the above stated concerns into account.
- Main changes (audit trail)
- RECORD25-mrt-2014 - 19-apr-2014


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