Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation
Primary Purpose
Amputation; Traumatic, Arm, Upper, Amputation; Traumatic, Arm: Forearm, Amputation; Traumatic, Hand, at Wrist Level
Status
Unknown status
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
ORTHOPUS prosthetic accessory: 0109 - Universal Wrist
ORTHOPUS prosthetic terminal device: 0112 - Hook
ORTHOPUS prosthetic terminal device: 0105 - Cosmetic Articulated Hand
ORTHOPUS prosthetic accessory: 0104 - body powered harness
Sponsored by
About this trial
This is an interventional treatment trial for Amputation; Traumatic, Arm, Upper focused on measuring amputation, transradial, prosthesis, terminal device, upper limb amputation, upper extremity
Eligibility Criteria
Inclusion Criteria:
- Unilateral transradial or wrist-disarticulation amputee
- 20 to 50 years of age
- At least 1 year from date of amputation
- Have been using upper limb prosthesis previously
- Be able to independently provide informed and independant consent
- Be willing to comply with study procedures
- Independent function by self-report
- Free of any health ailment that would impair physical function
Exclusion Criteria:
- Congenital anomaly of upper limb
- Bilateral wrist disarticulation or transradial amputation
- Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers)
- Injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures).
- Younger than 20 or older than 50 years of age
- Unwillingness/inability to follow instructions
- History of acute or chronic skin breakdown on the residual limb
- Any health ailment that would impair physical function
Sites / Locations
- Prerana Rehabilitation CenterRecruiting
- Community Based RehabilitationRecruiting
- Social Welfare Council - National Disabled FundRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants using the ORTHOPUS set of prosthetic solution
Arm Description
Outcomes
Primary Outcome Measures
Functionalities of the prosthetic solution
Users' feedback will be gathered from his/her experiences and quantitative data will be collected using the "OPUS Upper Extremity Functional Status" survey, which allows us to evaluate the contribution of the set of solutions to the accomplishment of daily life tasks. For each activity, the user will evaluate the difficulty of performing the activity (very easy; easy; slightly difficult; very difficult; cannot perform the task; not applicable), and will specify whether or not he or she usually uses his or her prosthesis in performing the task.
Quality of life evolution
Quality of life will be evaluated with the "WHO QOL - BREF quality of life assessment". The form is composed of checkboxes entries ranking from: very low, low, neither good nor low, good, very good. Users will have to fill in the form twice: once before the patient testing and a then at the end of it. This will allow a comparison of the results and the determination of a potential improvement.
Prosthesis perception
Prosthesis perception will be evaluated with a final questionnaire created by ORTHOPUS to collect users' feedback on aesthetics, functionalities and sensations. These aspects will be evaluated with scores from 1 to 5.
Secondary Outcome Measures
Full Information
NCT ID
NCT04803253
First Posted
March 15, 2021
Last Updated
September 8, 2021
Sponsor
Orthopus
Collaborators
Handicap International
1. Study Identification
Unique Protocol Identification Number
NCT04803253
Brief Title
Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopus
Collaborators
Handicap International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 R&D 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, 0.5% of the populations need these services and a report from the United Nations highlights that 0.7% of the Nepalese populations are physically disabled - NEPAL: Disabled Population 2011, (UNRCHCO, 2011). Prosthetics and Orthotics (P&O) 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, P&O 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 free/Open 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 1.94% 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 72.5% 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 connection/disconnection 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' R&D 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 solutions.pdf) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation; Traumatic, Arm, Upper, Amputation; Traumatic, Arm: Forearm, Amputation; Traumatic, Hand, at Wrist Level, Wounds and Injuries
Keywords
amputation, transradial, prosthesis, terminal device, upper limb amputation, upper extremity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants using the ORTHOPUS set of prosthetic solution
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ORTHOPUS prosthetic accessory: 0109 - Universal Wrist
Intervention Description
The ORTHOPUS mechanical wrist device is intended to provide an external wrist joint only for external upper limb prostheses with pronation/supination passive motion (activation with external force), a quick connection (with automatic lock) and manual disconnection of the mechanical wrist connectors.
The mechanical wrist connector allows to quickly switch between different type of terminal devices (hand or tools).
Intervention Type
Device
Intervention Name(s)
ORTHOPUS prosthetic terminal device: 0112 - Hook
Intervention Description
The ORTHOPUS body-powered hook is a Voluntary Opening (VO) device made of aluminium intended to provide high grasping capabilities under harsh environments.
Intervention Type
Device
Intervention Name(s)
ORTHOPUS prosthetic terminal device: 0105 - Cosmetic Articulated Hand
Intervention Description
The ORTHOPUS cosmetic articulated hand is intended to provide a replacement limb in order to hide the loss of the original one. It is composed of an aesthetic glove (18 colors and 3 sizes, silicone made) and of an internal structure that can be bent to achieve a given position allowing the user to grasp small and light objects.
Intervention Type
Device
Intervention Name(s)
ORTHOPUS prosthetic accessory: 0104 - body powered harness
Intervention Description
The ORTHOPUS body powered harness is intended to allow the patient to actuate the 0112 - Hook device. It will be installed on the patient's contralateral shoulder and linked to the 0112 - Hook device with a cable.
Primary Outcome Measure Information:
Title
Functionalities of the prosthetic solution
Description
Users' feedback will be gathered from his/her experiences and quantitative data will be collected using the "OPUS Upper Extremity Functional Status" survey, which allows us to evaluate the contribution of the set of solutions to the accomplishment of daily life tasks. For each activity, the user will evaluate the difficulty of performing the activity (very easy; easy; slightly difficult; very difficult; cannot perform the task; not applicable), and will specify whether or not he or she usually uses his or her prosthesis in performing the task.
Time Frame
1 month
Title
Quality of life evolution
Description
Quality of life will be evaluated with the "WHO QOL - BREF quality of life assessment". The form is composed of checkboxes entries ranking from: very low, low, neither good nor low, good, very good. Users will have to fill in the form twice: once before the patient testing and a then at the end of it. This will allow a comparison of the results and the determination of a potential improvement.
Time Frame
1.5 month
Title
Prosthesis perception
Description
Prosthesis perception will be evaluated with a final questionnaire created by ORTHOPUS to collect users' feedback on aesthetics, functionalities and sensations. These aspects will be evaluated with scores from 1 to 5.
Time Frame
1.5 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral transradial or wrist-disarticulation amputee
20 to 50 years of age
At least 1 year from date of amputation
Have been using upper limb prosthesis previously
Be able to independently provide informed and independant consent
Be willing to comply with study procedures
Independent function by self-report
Free of any health ailment that would impair physical function
Exclusion Criteria:
Congenital anomaly of upper limb
Bilateral wrist disarticulation or transradial amputation
Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers)
Injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures).
Younger than 20 or older than 50 years of age
Unwillingness/inability to follow instructions
History of acute or chronic skin breakdown on the residual limb
Any health ailment that would impair physical function
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thibault Davasse
Phone
0652341166
Ext
+33
Email
thibault.davasse@orthopus.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yeti Raj Niraula
Phone
9810031819
Ext
+977
Email
yr.niraula@hi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gouaillier, PhD
Organizational Affiliation
Orthopus
Official's Role
Study Director
Facility Information:
Facility Name
Prerana Rehabilitation Center
City
Sarlahi
State/Province
Malangawa
ZIP/Postal Code
45800
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Prasad Gurung
Phone
9841039153
Ext
+977
Email
mingurung687@gmail.com
Facility Name
Community Based Rehabilitation
City
Biratnagar
ZIP/Postal Code
56613
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kanulal Chaudhary
Phone
21531594
Ext
+977
Email
cbrbmanager@gmail.com
Facility Name
Social Welfare Council - National Disabled Fund
City
Kathmandu
ZIP/Postal Code
3249
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeti Raj Niraula
Phone
9810031819,
Ext
+977
Email
yr.niraula@hi.org
First Name & Middle Initial & Last Name & Degree
Ram Bahadur Thapa
Phone
9841155157
Ext
+977
Email
rampo.ndf@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation
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