Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation

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.

Conditions

• Amputation; Traumatic, Arm, Upper
• Amputation; Traumatic, Arm: Forearm
• Amputation; Traumatic, Hand, at Wrist Level
• Wounds and Injuries

Interventions

DEVICE

ORTHOPUS prosthetic accessory: 0109 - Universal Wrist

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).

DEVICE

ORTHOPUS prosthetic terminal device: 0112 - Hook

The ORTHOPUS body-powered hook is a Voluntary Opening (VO) device made of aluminium intended to provide high grasping capabilities under harsh environments.

DEVICE

ORTHOPUS prosthetic terminal device: 0105 - Cosmetic Articulated Hand

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.

DEVICE

ORTHOPUS prosthetic accessory: 0104 - body powered harness

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.

Sponsors & Collaborators

• Handicap International

  collaborator OTHER

• Orthopus

  lead INDUSTRY

Principal Investigators

• David Gouaillier, PhD · Orthopus

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-06

Primary Completion

2022-01-31

Completion

2022-02-28

Countries

• Nepal

Study Locations