Validation of the Spasticity Related Quality of Life Questionnaire (SQOL-6D)

Ipsen

Status: Completed

Conditions: Spasticity, Muscle

Treatments: Other: Data collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03442660

F-FR-52120-232

Details and patient eligibility

About

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 spasticity.

Full 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 one on-site visit not necessarily part of routine clinical practice.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

Data collection

Other group

Description:

An electronic data capture (EDC) system will be used to collect data in electronic format. Data will be collected at the enrolment visit, at the follow-up visit (8 weeks +/-2 weeks) and 1 to 4 days after the follow-up visit.

Treatment:

Other: Data collection