Validation of the Spasticity Related Quality of Life Questionnaire (SQOL-6D)
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|ClinicalTrials.gov Identifier: NCT03442660|
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spasticity, Muscle||Other: Data collection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity|
|Actual Study Start Date :||May 25, 2018|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
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
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.
- 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
- EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels) [ Time Frame: 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.
- Neurological Impairment Scale adapted for ULS (ULS-NIS) [ Time Frame: 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) [ Time Frame: 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).
- Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity) [ Time Frame: 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.
- ArmA (Arm Activity Measure) Scores [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442660
|Hull and East Yorkshire NHS Trust, Castle Hill Hospital|
|Cottingham, United Kingdom, HU16 5JQ|
|Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital|
|Dewsbury, United Kingdom, WF13 4HS|
|London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit|
|Harrow, United Kingdom, HA1 3UJ|
|University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital|
|Leicester, United Kingdom, LE5 4PW|
|Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation|
|Newcastle, United Kingdom, NE6 4QD|
|Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital|
|Stoke-on-Trent, United Kingdom, ST6 7AG|
|City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre|
|Sunderland, United Kingdom, SR4 7TP|
|South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital|
|Warwick, United Kingdom, CV34 6SR|
|Study Director:||Ipsen Medical Director||Ipsen|