Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr Andrew Roberts


Contact details

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
SY10 7AG
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised interventional treatment trial of the production of ankle-foot orthoses by laser scanning or existing methods in patients referred for rigid and hinged orthoses



Study hypothesis

The trial tests new technologies for producing ankle-foot orthoses (AFOs). AFOs are externally applied splints, usually customised to the particular needs of patients, the majority being children with neuromuscular conditions such as cerebral palsy that cause difficulties in controlling movement. The traditional method for producing orthotic devices involves the time-consuming use of plaster of Paris. This method often requires further fitting and adjustment of the orthosis after delivery to the patient.

Laser scanning with computer-aided design and manufacture (LSCAD/CAM) could enable a mould to be created much more quickly, accurately and cheaply once the equipment is purchased, thus helping the NHS to overcome a shortage of skilled orthotists. This technology is used widely in North America but has not yet been used in the NHS or adequately compared to the traditional method. ABLE is a randomised trial to estimate the costs to the NHS and benefits to patients of LSCAD/CAM comparing these with the present approach of creating moulds using plaster of Paris. While laser scanners offer the possibility of large potential benefits, the capital costs of LSCAD/CAM and costs of training orthotists in its use can be a deterrent to its purchase within the NHS. Our Trust provides one of the largest in-house orthotic services in the NHS and has recently acquired the LSCAD/CAM equipment.

If successful, the laser scanning system could be used for all types of orthoses currently produced by the traditional plastering method (e.g., spinal braces, head and neck orthoses, insoles and foot orthoses). A scanner may remove the need for return visits for re-casting because growth can be scaled into the first virtual cast and renewal orthoses can be sent by post. This technology could lead to greater integration and effectiveness of services at specialist orthotic centres where multidisciplinary teams can provide a strong clinical lead to the benefit of many patients.

Ethics approval

West Midlands REC Board approved on the 15/08/2007 (ref: 07/Q2604/85)

Study design

Randomised interventional treatment trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal


The intervention will include the production of a plaster cast and a virtual moulding using laser scanning with computer aided design and manufacture. Participants will experience both the plaster casting and scanning methods before being randomly allocated to have their AFO made from one of the two methods. The total duration of treatment is one of the outcomes of the study. The total duration of the study follow up is twelve months.

Study entry: single randomisation only

Intervention type



Phase III

Drug names

Primary outcome measure

Time from referral to delivery of ankle-foot orthoses

Secondary outcome measures

Health service and societal costs from referral for AFO to 12 months

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

All patients up to 21 years of age, either sex, referred for rigid and hinged ankle-foot orthoses

Participant type


Age group




Target number of participants

Planned sample size: 150; UK sample size: 150

Participant exclusion criteria

1. Do not consent to the study
2. Considered by the orthotist to be unsplintable
3. Unable to communicate directly or via a parent/carer
4. The AFO requested is the Saltiel type

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
SY10 7AG
United Kingdom

Sponsor information


Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust (UK)

Sponsor details

SY10 7AG
United Kingdom

Sponsor type

Not defined



Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2016 results in:

Publication citations

Additional files

Editorial Notes

28/10/2016: Publication reference added