Status:
COMPLETED
Validation of the Spasticity Related Quality of Life Questionnaire
Lead Sponsor:
Ipsen
Conditions:
Spasticity, Muscle
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to describe the psychometric properties (validity, reliability and responsiveness) of the SQOL-6D instrument in the context of routine clinical treatment of upper limb spas...
Detailed Description
The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection procedures include multiple questionnaire assessments and o...
Eligibility Criteria
Inclusion
- Currently resident in the UK
- Subjects with a diagnosis of ULS
- Receiving a treatment at the enrolment visit, as part of their routine clinical management, aiming at reducing spasticity
- Sufficient grasp of English and cognitive ability to be able to understand the SQOL-6D questions, give informed consent and complete the protocol requirements as judged by the investigator
Exclusion
- The subject has already been included in the study
- The subject, in the opinion of the investigator, would be unable to understand the questionnaire or to comply with the requirements of the study
Key Trial Info
Start Date :
May 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2019
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03442660
Start Date
May 25 2018
End Date
August 9 2019
Last Update
September 30 2019
Active Locations (8)
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1
Hull and East Yorkshire NHS Trust, Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
2
Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital
Dewsbury, United Kingdom, WF13 4HS
3
London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit
Harrow, United Kingdom, HA1 3UJ
4
University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital
Leicester, United Kingdom, LE5 4PW