Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04803253
Status:
UNKNOWN
Last Update Posted:
2021-09-16
First Post:
2021-03-15
Brief Title:
Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation
Sponsor:
Orthopus
Organization:
Orthopus
Study Overview
Official Title:
Evaluating the Relevance of Social and Professional Reintegration Improvements With a Set of Solutions for People With Upper Limb Amputation Longitudinal Analysis of 2 Cohorts in Selected Areas of Nepal
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ORTHOPUS develops assistive technologies to address the lack of availability of medical devices in low and middle income countries
With the help of HI Handicap International Nepal the need for upper limb prostheses was identified Indeed according to the literature - especially Efficiency of voluntary opening hand and hook prosthetic devices 24 years of development JRRD Volume 49 Number 4 2012 - today available solutions do not fully address patients needs
In Nepal only 2 upper limb prostheses options are generally proposed to patients because of supply and cost constraints
ORTHOPUS objective is to extend patients autonomy with a new set of prosthetic solutions By offering low cost but high quality devices according to CE marking requirements another of the ORTHOPUS missions is also to address supply and cost constraints
To improve patients capabilities ORTHOPUS aims at extending grasping capabilities compared to the usual passive aesthetic hand or voluntary opening one by proposing the following set of solutions
an aesthetic articulated hand
a mechanical wrist
a work hook
In order to assess the different stated hypotheses a clinical trial is set jointly with HI Nepal 14 patients will be enrolled in 2 cohorts n1 7 n2 7 the first one is constituted with patients usually using an aesthetic passive hand whereas the second one comprise patients normally equipped with voluntary opening hand
After selecting and getting the informed consent of the patients a month to make the sockets and adapt it to patients is planned An evaluation of their quality of life will be done with the WHO QOL - BREF quality of life assessment before and after the test period of the trial
ORTHOPUS set of prosthetic solutions will be tested by them over one month They will have to fill on a daily basis a survey OPUS assessing their use of the prostheses At the end of the test period different questionnaires and surveys will be filled during a last interview to collect data
Data will be analysed in order to extract evidence for or against the trial hypotheses With these results a report will be written and submitted to the GATE Global Cooperation on Assistive Health Technology community managed by WHO This report will also feed the ORTHOPUS RD with patients feedbacks and research findings will be shared publicly on different social media in respect with patient privacy
With the help of HI Handicap International Nepal the need for upper limb prostheses was identified Indeed according to the literature - especially Efficiency of voluntary opening hand and hook prosthetic devices 24 years of development JRRD Volume 49 Number 4 2012 - today available solutions do not fully address patients needs
In Nepal only 2 upper limb prostheses options are generally proposed to patients because of supply and cost constraints
ORTHOPUS objective is to extend patients autonomy with a new set of prosthetic solutions By offering low cost but high quality devices according to CE marking requirements another of the ORTHOPUS missions is also to address supply and cost constraints
To improve patients capabilities ORTHOPUS aims at extending grasping capabilities compared to the usual passive aesthetic hand or voluntary opening one by proposing the following set of solutions
an aesthetic articulated hand
a mechanical wrist
a work hook
In order to assess the different stated hypotheses a clinical trial is set jointly with HI Nepal 14 patients will be enrolled in 2 cohorts n1 7 n2 7 the first one is constituted with patients usually using an aesthetic passive hand whereas the second one comprise patients normally equipped with voluntary opening hand
After selecting and getting the informed consent of the patients a month to make the sockets and adapt it to patients is planned An evaluation of their quality of life will be done with the WHO QOL - BREF quality of life assessment before and after the test period of the trial
ORTHOPUS set of prosthetic solutions will be tested by them over one month They will have to fill on a daily basis a survey OPUS assessing their use of the prostheses At the end of the test period different questionnaires and surveys will be filled during a last interview to collect data
Data will be analysed in order to extract evidence for or against the trial hypotheses With these results a report will be written and submitted to the GATE Global Cooperation on Assistive Health Technology community managed by WHO This report will also feed the ORTHOPUS RD with patients feedbacks and research findings will be shared publicly on different social media in respect with patient privacy
Detailed Description:
BACKGROUND
ORTHOPUS is a french private company founded in 2018 with the mission of increasing access to assistive technology like prosthetics care ORTHOPUS focuses its actions on low and middle income countries with a model that mixes social impact open source frugal innovation fair pricing and medical european quality CE marking
Today over 1 billion people need at least one form of Assistive Technology AT but over 900 million people 90 do not have access to the AT they require
The number of people who need AT is expected to grow to more than 2 billion people by 2050 according to the WHO Assistive Technology Fact Sheet 18 May 2018 80 of these persons live in a Low or Middle Income Country LMIC
According to World Health Organization estimation 05 of the populations need these services and a report from the United Nations highlights that 07 of the Nepalese populations are physically disabled - NEPAL Disabled Population 2011 UNRCHCO 2011 Prosthetics and Orthotics PO service is the subset of rehabilitation service and National health policy 2019 has identified rehabilitation as core health services
Compared to other assistive products such as crutches and walkers PO services are very scarcely available in Nepal even-though its need is going higher due to the increasing prevalence of NCDs and road traffic injury
Living Conditions among People with Disability in Nepal report SINTEF 2015 highlights that 73 percent of people with disabilities do not have access to Assistive Devices
According to WHO failure of health policies excessive prices of products provision difficulties and insufficient training of health personnel are the 4 reasons for this problem
RATIONALE
ORTHOPUS objective is to address some of the problem highlighted by WHO
To address LMIC product-related problems ORTHOPUS proposes quality prosthetic solutions with a moderate price by designing innovative solutions based on the frugal innovation concept
To address Information transmission and Health care practitioner formation all ORTHOPUS solutions will be shared via a freeOpen source licence
In order to guarantee the quality of medical devices ORTHOPUS follows European standards certification process for each and every product
Nepal is one of the target countries of the ORTHOPUS objective as the 2011 Nepal Census conducted by the government of Nepal reported that 194 of the total population of Nepal is living with some kind of disabilities The number will be more if the functioning status of the population is considered
Moreover the Living Conditions among People with Disability in Nepal report SINTEF 2015 highlights that 83 percent of people with disabilities do not have access to rehabilitation services and that there is a 725 service gap in Assistive Devices
Today according to the Principal Investigator of the trial the most popular solutions provided by healthcare practitioners in LMICs such as Nepal for transradial amputation is a voluntary opening hand or a passive aesthetics one
The voluntary opening hand is a compromise between efficiency and aesthetics according to the publication Efficiency of voluntary opening hand and hook prosthetic devices 24 years of development JRRD Volume 49 Number 4 2012
On the other hand the passive aesthetic solution does not provide any active grasping functionalities but has an important social impact for users hiding the limb loss to a certain extent
In addition Nepal was chosen for ORTHOPUS first clinical trial thanks to the help of HI Humanity and Inclusion NGO who has already a program there HI staff Yeti Raj Niraula will be the principal investigator of this clinical trial
This clinical trial will focus on upper-limb prostheses ORTHOPUS wants to demonstrate that a set of solutions composed of multiple medical devices such as
a wrist with a possible pronosupination as well as a rotational lock and a quick connectiondisconnection feature
an aesthetic articulated hand similar to usual aesthetic passive hand proposed nowadays in Nepal but with an additional articulation feature
a heavy duty work hook used as a working tool to address the shortage of heavy duty prosthetic products in the country The trial aims at assessing if using this solution will improve work integration of the user
a harness used to actuate the work hook allowing the user to open it with muscular contraction of the upper part of the torso
With this trial improvement of the autonomy of users and on the well-being in everyday life will be studied compared to the sole use of a voluntary opening hand or a passive aesthetics one
GENERAL OBJECTIVE
The general objective is to show the relevance of using the set of solutions made by ORTHOPUS aesthetic articulated hand working hook and quick disconnect wrist compared to the widespread solution of a voluntary opening hand or passive aesthetic one
SPECIFIC OBJECTIVE
To establish the effect of the ORTHOPUS prosthetic solution four primary objectives will be studied to address the scientific question by collecting appropriate data
improvement of grasping capacities
improvement of quality of life
improvement of sociodemographic conditions
evaluation of prosthesis perception
To address the primary objectives of the trial the following subjective primary endpoints will be measured
improvement of grasping capacities will be evaluated using an adapted to Nepali culture OPUS survey Development and measurement properties of the Orthotics and Prosthetics Users Survey OPUS a comprehensive set of clinical outcome instruments A W Heinemann 2003 Participants will be ranking the ease of realisation of a 30 item list using ORTHOPUS prosthetic solution These ranks will be compared to the one obtained using the previous prosthetic solution if applicable Studying results to the survey a conclusion on the evolution of the grasping capacities of users will be formulated
improvement of quality of life will be evaluated using the WHOQoL-BREF questionnaire World Health Organisation Program of Mental Health WHOQOL-BREF introduction administration scoring and generic version of the assessment field trial version 1996 Participants will be asked to answer 27 questions with ranked propositions before and after the test phase of the clinical trial Scores will be compared to evaluate improvements brought by the ORTHOPUS prosthetic solution on the quality of life of the user and a conclusion will be drawn
improvement of sociodemographic conditions will be evaluated using a questionnaire written following the guidance of guidelines Standardization and Harmonization of Socio-Demographic Variables 2016 GESIS Survey Guidelines Again a comparison of the answers to the 28 entries of the form will be made confronting questionnaires filled before and after the clinical trial test phase
evaluation of prosthesis perception will be conducted using a questionnaire filled by participants at the end of the test phase of the clinical trial Analysis of the ranks given to the 90 entries will allow to draw a precise picture of the participants perception of the ORTHOPUS prosthesis solution With these results a conclusion will be drawn on the ORTHOPUS solution improvements that needs to be performed to improve future users perception
Results of evaluations of objectives achievements will be used to feed ORTHOPUS RD department in order to improve the studied prosthetic solution or to launch development of new products
RESEARCH HYPOTHESIS
Nowadays in Nepal most of the patients are equipped with either a voluntary opening hand or a passive aesthetic one These solutions present grasping capabilities or aesthetics limitations see additional document attached to the registration Comparative scheme - Standard VS ORTHOPUS prosthetic solutionspdf and we hypothesize that the ORTHOPUS prosthetic solution will expand it
In addition with this grasping capabilities expansion we hypothesize that compared to previously used prosthetic solution the set of ORTHOPUS upper limb prosthetics solutions will
improve the autonomy of users professional reintegration with the ability to perform manual work
improve the well-being in everyday life social reintegration
For the patient selection we hypothesize that two different cohorts will be enough to discriminate the data and make good clinical trial conclusions
The first cohort will be composed of prosthetic users usually equipped with aesthetic passive hand solutions The second one with a voluntary opening hand user Data gathered from both cohorts will allow a direct comparison between the use of voluntary opening hand or passive aesthetic one according to the cohort and the use of the ORTHOPUS prosthetic solution
ORTHOPUS is a french private company founded in 2018 with the mission of increasing access to assistive technology like prosthetics care ORTHOPUS focuses its actions on low and middle income countries with a model that mixes social impact open source frugal innovation fair pricing and medical european quality CE marking
Today over 1 billion people need at least one form of Assistive Technology AT but over 900 million people 90 do not have access to the AT they require
The number of people who need AT is expected to grow to more than 2 billion people by 2050 according to the WHO Assistive Technology Fact Sheet 18 May 2018 80 of these persons live in a Low or Middle Income Country LMIC
According to World Health Organization estimation 05 of the populations need these services and a report from the United Nations highlights that 07 of the Nepalese populations are physically disabled - NEPAL Disabled Population 2011 UNRCHCO 2011 Prosthetics and Orthotics PO service is the subset of rehabilitation service and National health policy 2019 has identified rehabilitation as core health services
Compared to other assistive products such as crutches and walkers PO services are very scarcely available in Nepal even-though its need is going higher due to the increasing prevalence of NCDs and road traffic injury
Living Conditions among People with Disability in Nepal report SINTEF 2015 highlights that 73 percent of people with disabilities do not have access to Assistive Devices
According to WHO failure of health policies excessive prices of products provision difficulties and insufficient training of health personnel are the 4 reasons for this problem
RATIONALE
ORTHOPUS objective is to address some of the problem highlighted by WHO
To address LMIC product-related problems ORTHOPUS proposes quality prosthetic solutions with a moderate price by designing innovative solutions based on the frugal innovation concept
To address Information transmission and Health care practitioner formation all ORTHOPUS solutions will be shared via a freeOpen source licence
In order to guarantee the quality of medical devices ORTHOPUS follows European standards certification process for each and every product
Nepal is one of the target countries of the ORTHOPUS objective as the 2011 Nepal Census conducted by the government of Nepal reported that 194 of the total population of Nepal is living with some kind of disabilities The number will be more if the functioning status of the population is considered
Moreover the Living Conditions among People with Disability in Nepal report SINTEF 2015 highlights that 83 percent of people with disabilities do not have access to rehabilitation services and that there is a 725 service gap in Assistive Devices
Today according to the Principal Investigator of the trial the most popular solutions provided by healthcare practitioners in LMICs such as Nepal for transradial amputation is a voluntary opening hand or a passive aesthetics one
The voluntary opening hand is a compromise between efficiency and aesthetics according to the publication Efficiency of voluntary opening hand and hook prosthetic devices 24 years of development JRRD Volume 49 Number 4 2012
On the other hand the passive aesthetic solution does not provide any active grasping functionalities but has an important social impact for users hiding the limb loss to a certain extent
In addition Nepal was chosen for ORTHOPUS first clinical trial thanks to the help of HI Humanity and Inclusion NGO who has already a program there HI staff Yeti Raj Niraula will be the principal investigator of this clinical trial
This clinical trial will focus on upper-limb prostheses ORTHOPUS wants to demonstrate that a set of solutions composed of multiple medical devices such as
a wrist with a possible pronosupination as well as a rotational lock and a quick connectiondisconnection feature
an aesthetic articulated hand similar to usual aesthetic passive hand proposed nowadays in Nepal but with an additional articulation feature
a heavy duty work hook used as a working tool to address the shortage of heavy duty prosthetic products in the country The trial aims at assessing if using this solution will improve work integration of the user
a harness used to actuate the work hook allowing the user to open it with muscular contraction of the upper part of the torso
With this trial improvement of the autonomy of users and on the well-being in everyday life will be studied compared to the sole use of a voluntary opening hand or a passive aesthetics one
GENERAL OBJECTIVE
The general objective is to show the relevance of using the set of solutions made by ORTHOPUS aesthetic articulated hand working hook and quick disconnect wrist compared to the widespread solution of a voluntary opening hand or passive aesthetic one
SPECIFIC OBJECTIVE
To establish the effect of the ORTHOPUS prosthetic solution four primary objectives will be studied to address the scientific question by collecting appropriate data
improvement of grasping capacities
improvement of quality of life
improvement of sociodemographic conditions
evaluation of prosthesis perception
To address the primary objectives of the trial the following subjective primary endpoints will be measured
improvement of grasping capacities will be evaluated using an adapted to Nepali culture OPUS survey Development and measurement properties of the Orthotics and Prosthetics Users Survey OPUS a comprehensive set of clinical outcome instruments A W Heinemann 2003 Participants will be ranking the ease of realisation of a 30 item list using ORTHOPUS prosthetic solution These ranks will be compared to the one obtained using the previous prosthetic solution if applicable Studying results to the survey a conclusion on the evolution of the grasping capacities of users will be formulated
improvement of quality of life will be evaluated using the WHOQoL-BREF questionnaire World Health Organisation Program of Mental Health WHOQOL-BREF introduction administration scoring and generic version of the assessment field trial version 1996 Participants will be asked to answer 27 questions with ranked propositions before and after the test phase of the clinical trial Scores will be compared to evaluate improvements brought by the ORTHOPUS prosthetic solution on the quality of life of the user and a conclusion will be drawn
improvement of sociodemographic conditions will be evaluated using a questionnaire written following the guidance of guidelines Standardization and Harmonization of Socio-Demographic Variables 2016 GESIS Survey Guidelines Again a comparison of the answers to the 28 entries of the form will be made confronting questionnaires filled before and after the clinical trial test phase
evaluation of prosthesis perception will be conducted using a questionnaire filled by participants at the end of the test phase of the clinical trial Analysis of the ranks given to the 90 entries will allow to draw a precise picture of the participants perception of the ORTHOPUS prosthesis solution With these results a conclusion will be drawn on the ORTHOPUS solution improvements that needs to be performed to improve future users perception
Results of evaluations of objectives achievements will be used to feed ORTHOPUS RD department in order to improve the studied prosthetic solution or to launch development of new products
RESEARCH HYPOTHESIS
Nowadays in Nepal most of the patients are equipped with either a voluntary opening hand or a passive aesthetic one These solutions present grasping capabilities or aesthetics limitations see additional document attached to the registration Comparative scheme - Standard VS ORTHOPUS prosthetic solutionspdf and we hypothesize that the ORTHOPUS prosthetic solution will expand it
In addition with this grasping capabilities expansion we hypothesize that compared to previously used prosthetic solution the set of ORTHOPUS upper limb prosthetics solutions will
improve the autonomy of users professional reintegration with the ability to perform manual work
improve the well-being in everyday life social reintegration
For the patient selection we hypothesize that two different cohorts will be enough to discriminate the data and make good clinical trial conclusions
The first cohort will be composed of prosthetic users usually equipped with aesthetic passive hand solutions The second one with a voluntary opening hand user Data gathered from both cohorts will allow a direct comparison between the use of voluntary opening hand or passive aesthetic one according to the cohort and the use of the ORTHOPUS prosthetic solution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None