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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11950127

Enrollment

Registered

2019-03-20

Start date

2019-02-01

Completion date

Unknown

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trans-radial upper limb difference (congenital/acquired/traumatic), aged 8-18 years Not Applicable

Interventions

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 th

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026