Condition category
Not Applicable
Date applied
18/01/2019
Date assigned
20/03/2019
Last edited
20/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
At present via the NHS, the majority of patients with upper limb differences are either provided with a passive prosthesis (cosmetic only), or a body-powered, single grip prosthesis. This limited choice reflects the cost-effectiveness and durability of these prostheses. However, almost half of all upper limb amputees abandon their prostheses, attributed primarily to a lack of function. With recent advances in robotics, the production of multi-grip prostheses that use muscle activity (myoelectric) to create movement, have become a reality. However, with the cost of these prostheses between £25, 000 - £80, 000, they are rendered inaccessible for the majority of patients. This study looks to address this problem. The researchers have taken the first steps in completing a small scale study within a single NHS centre, which established the ability to deliver the prosthesis in an NHS care pathway. The next step is to conduct a full clinical trial that will compare the Hero Arm™, a multigrip, myoelectric prosthesis, with standard care (a single-grip myoelectric prosthesis).

Who can participate?
Patients aged 8 to 18 who are trans-radial (forearm) upper limb amputees or with congenital (from birth) limb deficiencies

What does the study involve?
Participants use both prostheses in a random order over a period of 6 months (3 months with each prosthesis) and are assessed at the start of the study and after 3 and 6 months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. Bristol Centre for Enablement (UK)
2. Specialised Ability Centre Manchester, University Hospitals of Manchester (UK)

When is the study starting and how long is it expected to run for?
March 2018 to June 2020

Who is funding the study?
Innovate UK, SBRI Healthcare (UK)

Who is the main contact?
Dr Abby Tabor

Trial website

Contact information

Type

Scientific

Primary contact

Dr Abby Tabor

ORCID ID

Contact details

University of Bath
Claverton Down Rd
Bath
BA2 7AY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

244661

Study information

Scientific title

Affordable robotic prostheses in the NHS: a randomised controlled trial comparing the Hero Arm™ with the NHS standard upper limb myoelectric single grip prosthesis

Acronym

Affordable Prosthetics

Study hypothesis

The provision of an affordable, multigrip, robotic prosthesis is equal in performance, as measured through function in children and young people in comparison to standard care.

Ethics approval

London -Camberwell St Giles Research Ethics Committee, Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, Tel: +44 (0)20 7104 8044, 06/08/2018, REC ref: 18/LO/1228, IRAS project ID: 244661

Study design

Randomised controlled trial, crossover design, with stratified randomisation

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format

Condition

Trans-radial upper limb difference (congenital/acquired/traumatic), aged 8-18 years

Intervention

Having completed feasibility testing in a single centre, this Randomised Controlled Trial (stratified randomisation, with cross-over design) will involve recruitment from two NHS centres, comparing the Hero Arm™ with the standard care pathway currently commissioned in the NHS - a single grip myoelectric prosthesis. Specifically, the trial will engage a stratified randomisation, with participants stratified by age (8-13 years; 14-18 years) and previous prosthesis experience (novice, expert). This trial will also involve a cross-over design such that each participant tests each prosthesis sequentially for 3 months (6 months in total).

Intervention type

Device

Phase

Drug names

Primary outcome measure

Upper limb function measured using Action Research Arm Test at baseline, 3 and 6 months

Secondary outcome measures

Measured at baseline, 3 and 6 months:
1. Health-related quality of life measured using Paediatric QOL Inventory (PedsQL)
2. Self-reported function and symptoms in the upper limb measured using Disabilities of the Arm, shoulder and Hand (DASH)

Overall trial start date

01/03/2018

Overall trial end date

26/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 8 years – 18 years
2. Trans-radial (forearm), upper limb amputee
3. Established upper limb amputees: congenital limb deficiencies and post acquired limb loss more than 1-year post amputation

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

8

Participant exclusion criteria

1. Incomplete wound healing at residuum
2. Uncontrolled cardiovascular or respiratory conditions
3. Current multi-grip myoelectric prosthesis user

Recruitment start date

01/02/2019

Recruitment end date

28/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Centre for Enablement, North Bristol NHS Trust
Jupiter Rd, Patchway
Bristol
BS34 5BW
United Kingdom

Trial participating centre

Manchester Specialised Ability Centre
Altrincham Rd, Wythenshawe
Manchester
M22 4NY
United Kingdom

Sponsor information

Organisation

The University of Bath

Sponsor details

Claverton Down Rd
Bath
BA2 7AY
United Kingdom

Sponsor type

University/education

Website

www.bath.ac.uk

Funders

Funder type

Other

Funder name

SBRI Healthcare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Innovate UK

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Peer reviewed journal, open access (protocol and results)
2. International conference presentation

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Abby Tabor at the University of Bath. Once the study is closed (from June 2020) the data will be available, including quantitative and qualitative outcomes. The data will be stored for 5 years and can be accessed throughout this time. All data is anonymised, associated with a participant number. At the outset of the study, all participants are informed as part of their consent that they can access their data at the conclusion of the study. The lead researcher is able to determine the data in association with a particular participant without compromising ethical restrictions.

Intention to publish date

26/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes