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- Lendaro, Eva, 1989, et al.
(författare)
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Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain
- 2022
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215 .- 1745-6215. ; 23:1, s. 138-
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Phantom limb pain (PLP) is a detrimental condition that can greatly diminish the quality of life. Purposeful control over the phantom limb activates the affected neural circuitry and leads to dissolution of the pathological relationship linking sensorimotor and pain processing (which gives rise to PLP). An international, double-blind, randomized controlled clinical trial (RCT) on the use of phantom motor execution (PME) as a treatment for PLP is currently undertaken, where PME is compared to an active placebo treatment, namely phantom motor imagery (PMI). METHODS AND DESIGN: Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned in 2:1 ratio to PME or PMI interventions respectively. Subjects allocated to either treatment receive 15 interventions where they are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are performed (PME) or imagined (PMI). RESULTS: The primary outcome of the study is to examine whether 15 sessions of PME can induce a greater PLP relief, compared to PMI. The secondary objectives are to examine whether 15 sessions of PME provide a greater improvement in different aspects related to PLP compared to PMI, such as pain duration, pain intensity as measured by other metrics, and the patient's own impression about the effect of treatment. Long-term retention of treatment benefits will be assessed as change in all the variables (both primary and secondary) between baseline and follow-up timepoints (at 1, 3, and 6 months post-treatment). CONCLUSION: This manuscript serves as the formal statistical analysis plan (version 1.0) for the international, double-blind, randomized controlled clinical trial on the use of PME as a treatment for PLP. The statistical analysis plan was completed on 3 August 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT03112928 . Registered on April 13, 2017 SAP version: version: 1.0, date: 2021/08/03 Protocol version: This document has been written based on information contained in the study protocol published in Lendaro et al. (BMJ Open 8:e021039, 2018), in July 2018. SAP revisions: Not applicable.
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| 2. |
- Zbinden, Jan, 1994, et al.
(författare)
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A multi-dimensional framework for prosthetic embodiment: a perspective for translational research
- 2022
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Ingår i: Journal of NeuroEngineering and Rehabilitation. - : Springer Science and Business Media LLC. - 1743-0003. ; 19:1
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Forskningsöversikt (refereegranskat)abstract
- The concept of embodiment has gained widespread popularity within prosthetics research. Embodiment has been claimed to be an indicator of the efficacy of sensory feedback and control strategies. Moreover, it has even been claimed to be necessary for prosthesis acceptance, albeit unfoundedly. Despite the popularity of the term, an actual consensus on how prosthetic embodiment should be used in an experimental framework has yet to be reached. The lack of consensus is in part due to terminological ambiguity and the lack of an exact definition of prosthetic embodiment itself. In a review published parallel to this article, we summarized the definitions of embodiment used in prosthetics literature and concluded that treating prosthetic embodiment as a combination of ownership and agency allows for embodiment to be quantified, and thus useful in translational research. Here, we review the potential mechanisms that give rise to ownership and agency considering temporal, spatial, and anatomical constraints. We then use this to propose a multi-dimensional framework where prosthetic embodiment arises within a spectrum dependent on the integration of volition and multi-sensory information as demanded by the degree of interaction with the environment. This framework allows for the different experimental paradigms on sensory feedback and prosthetic control to be placed in a common perspective. By considering that embodiment lays along a spectrum tied to the interactions with the environment, one can conclude that the embodiment of prosthetic devices should be assessed while operating in environments as close to daily life as possible for it to become relevant.
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| 3. |
- Zbinden, Jan, 1994, et al.
(författare)
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Prosthetic embodiment: systematic review on definitions, measures, and experimental paradigms
- 2022
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Ingår i: Journal of Neuroengineering and Rehabilitation. - : Springer Science and Business Media LLC. - 1743-0003. ; 19:1
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Tidskriftsartikel (refereegranskat)abstract
- The term embodiment has become omnipresent within prosthetics research and is often used as a metric of the progress made in prosthetic technologies, as well as a hallmark for user acceptance. However, despite the frequent use of the term, the concept of prosthetic embodiment is often left undefined or described incongruently, sometimes even within the same article. This terminological ambiguity complicates the comparison of studies using embodiment as a metric of success, which in turn hinders the advancement of prosthetics research. To resolve these terminological ambiguities, we systematically reviewed the used definitions of embodiment in the prosthetics literature. We performed a thematic analysis of the definitions and found that embodiment is often conceptualized in either of two frameworks based on body representations or experimental phenomenology. We concluded that treating prosthetic embodiment within an experimental phenomenological framework as the combination of ownership and agency allows for embodiment to be a quantifiable metric for use in translational research. To provide a common reference and guidance on how to best assess ownership and agency, we conducted a second systematic review, analyzing experiments and measures involving ownership and agency. Together, we highlight a pragmatic definition of prosthetic embodiment as the combination of ownership and agency, and in an accompanying article, we provide a perspective on a multi-dimensional framework for prosthetic embodiment. Here, we concluded by providing recommendations on metrics that allow for outcome comparisons between studies, thereby creating a common reference for further discussions within prosthetics research.
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