Delivering affordable, functional prostheses in the NHS: a trial across two clinical sites to compare existing care with an affordable, multigrip prosthesis to increase function and choice for children and adolescents with upper limb difference

ISRCTN	ISRCTN11950127
DOI	https://doi.org/10.1186/ISRCTN11950127
Secondary identifying numbers	244661

Submission date: 18/01/2019
Registration date: 20/03/2019
Last edited: 20/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Contact information

Dr Abby Tabor
Scientific

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

Study information

Study design	Randomised controlled trial, crossover design, with stratified randomisation
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	Not available in web format
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
Study 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(s)	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
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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
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 study start date	01/03/2018
Overall study end date	26/06/2020

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	8
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 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

England
United Kingdom

Study participating centres

Bristol Centre for Enablement, North Bristol NHS Trust

Jupiter Rd, Patchway
Bristol
BS34 5BW
United Kingdom

Manchester Specialised Ability Centre

Altrincham Rd, Wythenshawe
Manchester
M22 4NY
United Kingdom

Sponsor information

The University of Bath
University/education

Claverton Down Rd
Bath
BA2 7AY
England
United Kingdom

Website	www.bath.ac.uk
"ROR"	https://ror.org/002h8g185

Funders

Funder type

Other

SBRI Healthcare

No information available

Innovate UK
Government organisation / National government

Alternative name(s): innovateuk
Location: United Kingdom

Results and Publications

Intention to publish date	26/07/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	1. Peer reviewed journal, open access (protocol and results) 2. International conference presentation
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No