Ankle-foot orthoses by laser-scanning or existing methods

ISRCTN	ISRCTN21404893
DOI	https://doi.org/10.1186/ISRCTN21404893
Secondary identifying numbers	4060

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 28/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Andrew Roberts
Scientific

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

Study information

Study design	Randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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 acronym	ABLE
Study objectives	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(s)	West Midlands REC Board approved on the 15/08/2007 (ref: 07/Q2604/85)
Health condition(s) or problem(s) studied	Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention	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	Other
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 study start date	26/02/2008
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Planned sample size: 150; UK sample size: 150
Key inclusion criteria	All patients up to 21 years of age, either sex, referred for rigid and hinged ankle-foot orthoses
Key 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
Date of first enrolment	26/02/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Shropshire
SY10 7AG
United Kingdom

Sponsor information

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust (UK)
Not defined

Oswestry
Shropshire
SY10 7AG
United Kingdom

Email	Teresa.jones@rjah.nhs.uk
Website	http://www.rjah.nhs.uk/
"ROR"	https://ror.org/030mbcp39

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2016		Yes	No

Editorial Notes

28/10/2016: Publication reference added