Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation
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.
1 other identifier
interventional
14
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedStudy Start
First participant enrolled
September 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedSeptember 16, 2021
September 1, 2021
4 months
March 15, 2021
September 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
1 month
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.
1.5 month
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.
1.5 month
Study Arms (1)
Participants using the ORTHOPUS set of prosthetic solution
EXPERIMENTALInterventions
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).
The ORTHOPUS body-powered hook is a Voluntary Opening (VO) device made of aluminium intended to provide high grasping capabilities under harsh environments.
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.
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.
Eligibility Criteria
You may qualify if:
- Unilateral transradial or wrist-disarticulation amputee
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orthopuslead
- Handicap Internationalcollaborator
Study Sites (3)
Prerana Rehabilitation Center
Sarlahi, Malangawa, 45800, Nepal
Community Based Rehabilitation
Biratnagar, 56613, Nepal
Social Welfare Council - National Disabled Fund
Kathmandu, 3249, Nepal
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
David Gouaillier, PhD
Orthopus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 17, 2021
Study Start
September 6, 2021
Primary Completion
January 1, 2022
Study Completion
February 1, 2022
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share