Study of the social and professional reintegration improvements using a set of solutions for people with upper limb amputation

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Registration number: NPCTR2021000012
Register By : David GOUAILLIER
Registered Date : 2021/03/12
Email : david.gouaillier@orthopus.com
Titles & IDs
Refrence Number : REF/2021/03/000064
Public Title : Study of the social and professional reintegration improvements using a set of solutions for people with upper limb amputation
Scientific 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 Nepal.
Trial Acronyms : None
Registration Type : Prospective
Secondary Id : NA
Recruitment Country : Nepal

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.

In addition with this grasping capabilities expansion (shown in figure “Comparative scheme - Standard VS ORTHOPUS prosthetic solutions” enclosed to the registration), we hypothesize that the set of 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)

ORTHOPUS’ prosthetic solution is composed of 3 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.

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.

Principal Investigator (Trail coordinator for multi centric study)

Principal Investigator ( 1 )

Name
Mr. Yeti Raj Niraula
Email
yr.niraula@hi.org
Contact No
9801975972
Designation
Senior Prosthetist & Orthotist – Capacity Building Officer
Orgnizational Affilation
Handicap International (Humanity and Inclusion)
Address
233 Sallaghari Marg, Kathmandu, Nepal | P.O Box:10179
Country
Nepal

Contact person (scientific query)
Name
David GOUAILLIER, Ph.D
Email
david.gouaillier@orthopus.com
Contact No
0698406138
Designation
Head of Research at ORTHOPUS SAS
Orgnizational Affilation
ORTHOPUS SAS
Address
ORTHOPUS Le Karting - Bloc 3, 6 rue de Saint Domingue, 44200 Nantes, FRANCE
Country
France, Metropolitan

Contact person (Public Query)
Name
Thibault DAVASSE
Email
thibault.davasse@orthopus.com
Contact No
0652341166
Designation
R&D Lead at ORTHOPUS
Orgnizational Affilation
ORTHOPUS SAS
Address
ORTHOPUS Le Karting - Bloc 3, 6 rue de Saint Domingue, 44200 Nantes, FRANCE
Country
France, Metropolitan

Contact person (Public Query)
Name
Thibault DAVASSE
Email
thibault.davasse@orthopus.com
Contact No
0652341166
Designation
R&D Lead at ORTHOPUS
Orgnizational Affilation
ORTHOPUS SAS
Address
ORTHOPUS Le Karting - Bloc 3, 6 rue de Saint Domingue, 44200 Nantes, FRANCE
Country
France, Metropolitan

Sponsor
Type
Others (Please specify)
Name
ORTHOPUS
Email
contact@orthopus.com
Contact
0698406138
Address
ORTHOPUS Le Karting, 6 rue Saint Domingue 44 200 Nantes FRANCE

Recruitment Country
Country
Nepal

Site(s) of study
Site Address
National Disabled Fund, Kathmandu
Contact Person Name
Mr. Ram Bahadur Thapa
Contact Person Email
rampo.ndf@gmail.com
Contact Person Contact
9841155157

Ethics Committees Informations
Ethics Committee
Ethics Committee Contact
Ethics Committee Address
Ethics Committee Email

Approvals
Status
Submitted/ Under review
Date
1970-01-01

Health condition(s)
Status
Particular health condition(s) or problem(s)

Study type
Thesis
No
Type of trial
Interventional
Study Type
Medical devices,

Study Design
Allocation
Single arm study
Masking
Open (masking not used)
Control
historical
Assignment
single
purpose
treatment
Trial Phase
N/A

Intervention and comparison
Intervention name
ORTHOPUS prosthetic accessory: 0109 - Wrist || ORTHOPUS prosthetic terminal device: 0112 - Hook || ORTHOPUS prosthetic terminal device: 0105 - Aesthetic Articulated Hand || ORTHOPUS prosthetic accessory: 0104 - body powered harness
Intervention details
  • ORTHOPUS prosthetic accessory: 0109 - 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)

  • 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.

  • ORTHOPUS prosthetic terminal device: 0105 - Aesthetic Articulated Hand

The ORTHOPUS aesthetic 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.

  • ORTHOPUS prosthetic accessory: 0104 - body powered harness

The ORTHOPUS body powered harness is intended to allow the patient to actuate the 0109 - Wrist device. It will be installed on the patient’s contralateral shoulder and linked to the 0109 - Wrist device with a cable.

Comparison name
Voluntary Opening Mechanical Hand, Aesthetic passive Hand
Comparison details

ORTHOPUS prosthetic terminal devices and accessories will be compared with previous prosthetic devices used by patients participating in the trial. Two cohorts will be constituted with patients previously equipped with aesthetic passive hands solutions or with voluntary opening hands


Eligibility (Inclusion criteria)
Age Group
Age from 20 to 50 years old
Gender
Both
Detail

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 Detail

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

Sample Size
14
Enrollment Date
2021-04-05
Completion Date
2021-09-10
Enrollment Status
Pending