Spasticity, Muscle
Conditions
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.
Interventions
OTHERData collection
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.
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of SQOL-6D in upper limb spasticity | Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit) | Validity - Reliability - Responsiveness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological Impairment Scale adapted for ULS (ULS-NIS) | Day 1 | 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). |
| Modified Ashworth Scale (MAS) | Day 1 and then 8 weeks +/-2 | 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). |
| EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels) | Day 1 and then 8 weeks +/-2 | 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. |
| ArmA (Arm Activity Measure) Scores | Day 1 and then 8 weeks +/-2 | 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). |
| Global assessment of benefit | 8 weeks +/-2 | 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). |
| Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity) | Day 1 and then 8 weeks +/-2 | 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. |
Countries
United Kingdom
Outcome results
None listed