Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity

Ipsen8 sites in 1 country104 target enrollmentMay 25, 2018

ConditionsSpasticity, Muscle

Overview

Phase: N/A
Intervention: Not specified
Conditions: Spasticity, Muscle
Sponsor: Ipsen
Enrollment: 104
Locations: 8
Primary Endpoint: Validation of SQOL-6D in upper limb spasticity
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 spasticity.

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

Registry

clinicaltrials.gov

Start Date

May 25, 2018

End Date

August 9, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Validation of SQOL-6D in upper limb spasticity

Time Frame: Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)

Validity - Reliability - Responsiveness

Secondary Outcomes

EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels)(Day 1 and then 8 weeks +/-2)
Neurological Impairment Scale adapted for ULS (ULS-NIS)(Day 1)
Modified Ashworth Scale (MAS)(Day 1 and then 8 weeks +/-2)
Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity)(Day 1 and then 8 weeks +/-2)
ArmA (Arm Activity Measure) Scores(Day 1 and then 8 weeks +/-2)
Global assessment of benefit(8 weeks +/-2)