In Ukraine, since the beginning of the full-scale war on February 24, 2022, a large number of individuals have lost a limb(s). 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.
Amputee has given written informed consent for participation in the study.
Male or Female
Age - no restriction but adult
Have undergone amputation of one limb, upper or lower.
None
People in Ukraine, soldiers or civilians, who have undergone an amputation of one limb, upper or lower, since the 2022 war.
Cohort
Prospective
non-pharmacological app
DeviceAmputees will be offered use of an app which offers a variety of non-pharmacological management techniques and exercises aimed at reducing the sensations and pain which are associated with amputation. These include: (1) offering information about the amputation, (2) augmented reality, this is a method for altering a person's perception about the real-world environment using computer simulation; (3) methods for reducing stress, also called 'Mindfulness-Based-Stress-Reduction' and (4) a method called 'Graded Motor Imagery' which aims to train the brain to address the changes which have occurred due to the amputation and which are related to pain and challenges with movement
To assess the feasibility of amputees completing a pre-defined 8-week Routine Health treatment protocol, tailored to each amputee.
To assess the feasibility of amputees cared for in rehabilitation centers in Ukraine being able to complete a pre-defined 8-week Routine Health treatment protocol, tailored to each amputee. This includes \[i\] whether the protocol was followed in terms of implementing the modules (duration \& frequency) and \[ii\] whether the assessments of the amputation-related outcomes, at the different assessment time points, were filled in.
Usability and acceptability of the app
Assess usability and acceptability of the app by amputees \& carers at 8 weeks.
Profile of amputees who completed the 8 week treatment protocol vs did not
Assess the profile of patients who were able to complete the 8-week treatment protocol vs those who did not. Assess in terms of demographics, type of injury, character of pain
Pain-related amputation patient reported outcomes
Assess information about pain-related patient reported outcomes obtained from the assessments carried out at baseline (=anamnesis), once weekly during the 8 week treatment and once weekly for another 4 weeks of independent use.
Profile of amputees who completed the 4 week independent use of the app vs did not
Assess the profile of patients who wished to continue using the app, independently, for an additional 4 weeks.
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Winfried Meißner
Lead sponsor
Jena University Hospital
Sponsor institution
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