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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Data collection | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull and East Yorkshire NHS Trust, Castle Hill Hospital | Cottingham | HU16 5JQ | United Kingdom | |||
| Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34726763 | Derived | Turner-Stokes L, Fheodoroff K, Jacinto J, Lambert J, De La Loge C, Calvi-Gries F, Whalen J, Lysandropoulos A, Maisonobe P, Ashford S. The spasticity-related quality of life 6-dimensions instrument in upper-limb spasticity: Part I Development and responsiveness. J Rehabil Med. 2022 Jan 3;54:jrm00244. doi: 10.2340/jrm.v53.690. |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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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 |
| Dewsbury |
| WF13 4HS |
| United Kingdom |
| London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit | Harrow | HA1 3UJ | United Kingdom |
| University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital | Leicester | LE5 4PW | United Kingdom |
| Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation | Newcastle | NE6 4QD | United Kingdom |
| Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital | Stoke-on-Trent | ST6 7AG | United Kingdom |
| City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre | Sunderland | SR4 7TP | United Kingdom |
| South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital | Warwick | CV34 6SR | United Kingdom |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |