Measuring functional outcome following treatment for leg spasticity V2
Research type
Research Study
Full title
Measuring functional outcome following treatment for leg spasticity V2
IRAS ID
150899
Contact name
Stephen Ashford
Contact email
Sponsor organisation
North West London Hospitals NHS Trust
Clinicaltrials.gov Identifier
CRD42013005046, PROSPERO register
Research summary
The Leg Activity measure (LegA), a Patient Reported Outcome Measure (PROM), has been developed. Items within Leg-A have been compiled using findings from a systematic review of existing measures of leg function (Ashford et al. In press) and detailed analysis of our extensive database of patient defined goals for lower limb spasticity treatment. In addition, physiotherapy interventions used in conjunction with botulinum toxin injection for the management of spasticity have been analysed from our database. These findings have been presented to experts in lower limb spasticity management through a Delphi consultation process. The Delphi process has resulted in the LegA and a system for recording therapy intervention (LegTS).
The purpose of the proposed study is to establish the psychometric (measurement) properties of LegA including:
• reliability – consistency in reporting results each time LegA is used
• validity – does the LegA measure what it purports to measure
• scaling properties - to what extent can the LegA be used as a numerical scale when measuring the impact of lower limb spasticity on functional activities
• responsiveness – can Leg-A detect change as a result of clinical intervention
• Utility and feasibility of LegA – Time to complete and perceived rater burden
These properties will be evaluated using the data collected during an observational study. The LegA will be tested at three sites, in the context of routine clinical practice for the managment of spasticity (muscle over-activity). The clinicians providing the services have agreed to participate and all specialise in the management of spasticity following acquired brain injury.REC name
London - South East Research Ethics Committee
REC reference
14/LO/1340
Date of REC Opinion
27 Aug 2014
REC opinion
Favourable Opinion