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Key studies

Measuring Functional Outcome Following Treatment for Leg Spasticity (FunctionalTLS)

Abstract

The importance of measuring the functional impact of treatments from the perspective of patients and their carers has been emphasised in the Department of Health Guidance on the routine collection of Patient Reported Outcome Measures (PROMs). However, there is currently no comprehensive instrument to measure function of the spastic lower limb, which may range from passive caring for the limb in severely disabled patients, to using the limb for active mobility in more able patients.

This project builds on our previous work in upper limb spasticity, to develop a measure of lower limb function. The content of the tool will be drawn from a systematic review of existing measures, together with analysis of our extensive database of goals for treatment. After consultation with expert clinicians the measurement properties of the tool will be examined in the context of a multicentre observational cohort study, conducted in the context of routine clinical practice.

Introduction

The importance of measuring the functional impact of interventions from the perspective of patients and their carers is emphasised in the Royal College of Physicians spasticity management guidelines and the Department of Health Guidance on the routine collection of Patient Reported Outcome Measures (PROMs) to evaluate the impact of treatments in the context of real life, as opposed to clinical observation within the hospital/clinic setting.

Lower limb spasticity following neurological illness/injury may cause a diverse range of problems depending on the severity of disability. Data on the prevalence of spasticity are varied, but it has been reported in between 19 and 38% of patients after stroke (Sommerfeld et al. 2004, Watkins et al. 2002), the proposed project will therefore have impact across a large proportion of patients. In the most disabled patients, problems with passive function include difficulty with caring for the limb such as maintaining perineal hygiene or dressing. In more able patients, spasticity may limit active function (mobility), due to problems with gait, balance, walking speed etc. The goals for treatment are therefore highly diverse.

Interventions to manage lower limb spasticity are similarly complex and diverse. They include various combinations of medical treatments (anti-spasmodic medications or focal interventions e.g. botulinum toxin) and physical intervention (e.g. stretching, splinting, muscle strengthening, motor-relearning through task practice etc.). In order to establish what types of intervention are most effective and cost-efficient for which patients, we need to record both inputs (type, amount and costs of physical intervention) and outcome.

As yet there is no comprehensive PROM which covers both active and passive aspects of lower limb function, and so captures the full range of goals for treatment in this context. Neither is there an agreed systematic framework for recording of inputs.

Aim

The aim of this project is to develop and undertake initial testing of a patient reported measure of function in the context of a spasticity index for the lower limb (including selection of other standardised measures), in conjunction with development of a method to record therapy inputs.

The proposed project builds on existing and on-going work that Dr Ashford has undertaken in development of the Upper limb Spasticity Index (ULSI) in collaboration with Professor Turner-Stokes and international colleagues. The proposed work will:

  • Develop a lower limb spasticity index involving the construction of a PROM measure, for use alongside existing measures included in the index.
  • Develop a system for accurate recording and categorisation of clinical intervention in a form that could be used directly for costing in future economic analyses.

It is anticipated that the proposed work will complement previous work in providing a holistic evaluation of this type of combined/complex intervention for upper and lower limb spasticity. Evaluation of the proposed measure would also involve ensuring the index and PROM can be used in future economic evaluation. It will therefore be necessary to ensure that the system of recording intervention is fit for this purpose.

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