SQOL-6D psychometric validation
Research type
Research Study
Full title
PSYCHOMETRIC VALIDATION STUDY OF THE SPASTICITY-RELATED QUALITY OF LIFE 6-DIMENSIONS (SQOL-6D) IN UPPER-LIMB SPASTICITY
IRAS ID
232862
Contact name
Lynne Turner-Stokes
Contact email
Sponsor organisation
Ipsen Pharma
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This study is a national, multicentre, interventional, non-CTIMP (non-clinical trial of an investigational medicinal product), prospective, longitudinal study designed to describe the psychometric properties (validity, reliability and responsiveness) of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) instrument in the context of routine clinical treatment of upper limb spasticity (ULS).
Spasticity (encompassing spasticity, spastic dystonia and muscle shortening) is a common feature of the upper motor neuron syndrome that follows injury or other damage to the central nervous system. It occurs in a wide variety of neurological conditions including acquired brain injury, spinal cord injury, multiple sclerosis and cerebral palsy. ULS typically occurs in subjects after a stroke or other acquired brain injury. Spasticity contributes to functional impairment, reduced activities of daily living and restriction of participation in society, and so impacts on quality of life. Understanding the impact of ULS on health-related quality of life (HRQL) can be very difficult due to the complex interaction of spasticity itself and other features of neurological disability (including motor weakness, limb deformity, cognitive, communicative, emotional and behavioral problems). To date, attempts to show change in HRQL following treatment for spasticity have been unsuccessful. The SQOL-6D was developed in that context to fulfil the need for a utility measure that would be sensitive to the disease burden and changes following treatment for ULS and that could be used in economic evaluation of treatments for ULS.
The study plans to enroll 100 subjects, male or female, aged 18 or over, resident in the UK, suffering from ULS, who are about to receive treatment aiming at reducing spasticity. Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional diagnostic or treatment procedures will be required. Subject participation duration is expected to be 8 weeks.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0449
Date of REC Opinion
28 Dec 2017
REC opinion
Further Information Favourable Opinion