Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604507
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Injury in Ukraine PAMELA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Amputation in Ukraine a Quantitative Qualitative Observational Trial in the Prevention and Management of Phantom Limb Pain Project
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAMELA
Brief Summary:
In Ukraine since the beginning of the full-scale war on February 24 2022 a large number of individuals have lost a limbs Many of these amputees cannot access appropriate care in terms of pain management and rehabilitation Consequently healthcare providers in Ukraine have been seeking assistance from international professional bodies to improve the care offered to amputees - soldiers and civilians
Pain related to an amputation is chronic and so non-pharmacological approaches rather than pharmacological are appealing In Germany Routine Health in Düsseldorf have developed an app-based platform which offers amputees a variety of non-pharmacological management techniques
In the PAMELA project we will offer amputees and therapists in Ukraine use of this app
The app has been adapted for use in Ukraine
The study will be carried out in 2 phases
1 A pilot in 5 rehabilitation centers to assess feasibility of using the app during one pre-defined 8-week treatment cycle tailored to each amputee amputees will be offered to use the app for another 4 weeks independently
2 Updating the app based on experience gained in the pilot phase and sharing the app with amputees who wish to us it
Pain related to an amputation is chronic and so non-pharmacological approaches rather than pharmacological are appealing In Germany Routine Health in Düsseldorf have developed an app-based platform which offers amputees a variety of non-pharmacological management techniques
In the PAMELA project we will offer amputees and therapists in Ukraine use of this app
The app has been adapted for use in Ukraine
The study will be carried out in 2 phases
1 A pilot in 5 rehabilitation centers to assess feasibility of using the app during one pre-defined 8-week treatment cycle tailored to each amputee amputees will be offered to use the app for another 4 weeks independently
2 Updating the app based on experience gained in the pilot phase and sharing the app with amputees who wish to us it
Detailed Description:
In Ukraine since the beginning of the full-scale war on February 24 2022 approximately 50000 individuals have lost a limbs Many of these amputees cannot access appropriate care in terms of pain management and rehabilitation Consequently healthcare providers in Ukraine have been seeking assistance from international professional bodies to improve the care offered to amputees - soldiers and civilians
The protocol outlined here is of a study which will offer amputees and their therapists in Ukraine support in treating pains associated with amputation using non-pharmaceutical methods
Pain related to an amputation is chronic and so non-pharmacological approaches rather than pharmacological are appealing In Germany Routine Health in Düsseldorf have developed an app-based platform which offers amputees a variety of non-pharmacological management techniques In Germany the app is s used by amputees injured in work-related accidents The developers have gained extensive experience over the last 7 years in terms of the apps usability and its effect on amputation-related pains
In the PAMELA project we will offer amputees and therapists in Ukraine use of this app We anticipate that an app-based solution can be feasible as many of the amputees are young and therefore computer savvy many as said to be motivated to regain their independence after their injury With the limited resources in terms of availability healthcare professionals in Ukraine we anticipate that offering amputees an app-based tool which can be used in different environments hospital rehabilitation centers or home at different phases of their treatment might be an effective and cost effective means for managing amputation-related pains
The app has been adapted for use in Ukraine - modules have been translated into Ukrainian and we devised methodology for assessing demographics of the amputees information about the injury and amputation-related pain and other symptoms The literature stresses that when proving this form of non-pharmacological management it is important to select suitable candidates train them and tailor their care Thus at least for the first phase of the study pilot staff from Routine Health will train Ukrainian therapists physiotherapists and occupational therapists from 5 centers on how to use the app and they will recruit amputees in the center in which they work
The study will be carried out in 2 phases
1 A pilot in 5 rehabilitation centers to assess feasibility of using the app during one pre-defined 8-week treatment cycle tailored to each amputee amputees will be offered to use the app for another 4 weeks independently
2 Updating the app based on experience gained in the pilot phase and sharing the app with amputees who wish to us it
The protocol outlined here is of a study which will offer amputees and their therapists in Ukraine support in treating pains associated with amputation using non-pharmaceutical methods
Pain related to an amputation is chronic and so non-pharmacological approaches rather than pharmacological are appealing In Germany Routine Health in Düsseldorf have developed an app-based platform which offers amputees a variety of non-pharmacological management techniques In Germany the app is s used by amputees injured in work-related accidents The developers have gained extensive experience over the last 7 years in terms of the apps usability and its effect on amputation-related pains
In the PAMELA project we will offer amputees and therapists in Ukraine use of this app We anticipate that an app-based solution can be feasible as many of the amputees are young and therefore computer savvy many as said to be motivated to regain their independence after their injury With the limited resources in terms of availability healthcare professionals in Ukraine we anticipate that offering amputees an app-based tool which can be used in different environments hospital rehabilitation centers or home at different phases of their treatment might be an effective and cost effective means for managing amputation-related pains
The app has been adapted for use in Ukraine - modules have been translated into Ukrainian and we devised methodology for assessing demographics of the amputees information about the injury and amputation-related pain and other symptoms The literature stresses that when proving this form of non-pharmacological management it is important to select suitable candidates train them and tailor their care Thus at least for the first phase of the study pilot staff from Routine Health will train Ukrainian therapists physiotherapists and occupational therapists from 5 centers on how to use the app and they will recruit amputees in the center in which they work
The study will be carried out in 2 phases
1 A pilot in 5 rehabilitation centers to assess feasibility of using the app during one pre-defined 8-week treatment cycle tailored to each amputee amputees will be offered to use the app for another 4 weeks independently
2 Updating the app based on experience gained in the pilot phase and sharing the app with amputees who wish to us it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None