Validation of the Spasticity Related Quality of Life Questionnaire

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spasticity, Muscle

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Data collection<br>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. | Other: Data collection<br>* 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. Subjects will be asked to complete electronic (or on paper when it's not possible to use electronic version) questionnaires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of SQOL-6D in upper limb spasticity | Validity - Reliability - Responsiveness | Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels) | A summary index score will be calculated from responses given to the 5 domain items, measuring overall health on a scale 0 to 1 using United Kingdom (UK) value sets. | Day 1 and then 8 weeks +/-2 | 
| Neurological Impairment Scale adapted for ULS (ULS-NIS) | Records functional impairment on a four-point scale (rated 0-3) across seven domains, including: motor impairment in the affected upper limb, sensation affected in the affected upper limb, communication, cognitive function, cortical function, emotional/behaviour and mobility of joints, as measured by soft tissue shortening (an assessment used for the evaluation of the deterioration in range of movement due to spasticity by percentage loss of range). | Day 1 | 
| Modified Ashworth Scale (MAS) | Six-point scale (with available scores of 0, 1, 1+, 2, 3 and 4) evaluates muscle tone by reporting changes in this during muscle flexion or extension, depending on the (resistance in) joint mobility being assessed (shoulder, elbow, wrist or finger). | Day 1 and then 8 weeks +/-2 | 
| Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity) | Goal attainment will be recorded on a five point numerical scale (range -2 to +2) and goal scores combined to give an aggregated T score. | Day 1 and then 8 weeks +/-2 | 
| ArmA (Arm Activity Measure) Scores | ArmA is a patient-reported outcomes questionnaire recording the difficulty in caring for, and completing tasks and activities with the affected arm. The ArmA contains a total of 29 items in four subscales. Difficulty for each item is assessed on a five-point scale (range 0 to 4). | Day 1 and then 8 weeks +/-2 | 
| Global assessment of benefit | The Global Assessment of Benefit scale will be completed by the subject. Responses options will be: Much worse (-2)/Worse (-1)/Same (0)/Some benefit (+1)/Great benefit (+2). | 8 weeks +/-2 |