Muscle spasticity is common in adult-onset neurological conditions such as stroke, traumatic brain injury, multiple sclerosis, and spinal cord injury. It is a major contributor to disability and the economic burden of disease. Muscle spasticity may cause bodily dysfunction such as pain, contracture or reduced skin integrity and has been shown to negatively impact mobility, upper limb function, personal-care, and quality of life. While there is level-A evidence to support that interventions such as BoNT-A are effective in reducing muscle spasticity, related studies and systematic reviews have found insufficient evidence of improved function associated with the reduction in spasticity.
Clinical trials evaluating the effectiveness of spasticity interventions are plagued by poor reporting of trial outcomes. Lack of a standardized approach to measurement in spasticity research hampers the ability to advance understanding of recovery mechanisms, devise better treatments and consolidate knowledge.
This study has been designed to develop a ‘core set’ of outcome measures, containing a minimum set of outcomes to be measured and reported in spasticity trials and clinical practice.
Related COS
There are two other spasticity related registered COS. First, https://www.comet-initiative.org/Studies/Details/2608
This COS is specific to the use of acupuncture and moxibustion for the treatment of post-stroke spasticity. In contrast, our proposed COS will be developed to target all studies that focus on adults receiving any form of intervention with spasticity of any origin.
Second, https://www.comet-initiative.org/Studies/Details/3033. This COS is specific to paediatric upper limb spasticity affecting people with cerebral palsy. In contrast, our proposed COS will be developed to target adults receiving any form of intervention to the upper or lower limb with spasticity of any origin.
In summary, our proposed COS will be developed to target all adults with spasticity of any origin, to any limb, receiving any type of intervention.
Principal investigator
Professor Gavin Williams - The University of Melbourne and Epworth Healthcare
Associate investigators:
A/Prof Stephan Ashford - Northwick Park Hospital and Kings College, London
Dr Megan Banky - The University of Melbourne and Epworth Healthcare
Dr Hannah Barden - Brain Injury Rehabilitation Service, Sydney
Dr Bridget Hill - The University of Melbourne and Epworth Healthcare
A/Prof Lisa Shaw - Newcastle University
Disease Category: Neurology
Disease Name: Spasticity
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Pharmaceutical industry representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Semi structured discussion
- Systematic review
This study will use data from systematic reviews of clinical guidelines for the management of spasticity and semi structured interview with consumers to identify outcome domains relevant to all stakeholders. Through a modified Delphi process the key domains perceived to be relevant to all stakeholders will be selected. Systematic reviews will then be used to identify relevant outcome measures that assess each key domain. A second Delphi will be undertaken to select the most appropriate outcome measure for each domain.