Validation of the Spasticity Related Quality of Life Questionnaire

Not Applicable

Completed

• Conditions: Spasticity, Muscle
• Interventions: Other: Data collection

• Registration Number: NCT03442660
• Lead Sponsor: Ipsen

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.

Study Timeline

• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Study Start: 2018-05-25
• Primary Completion: 2019-08-09
• Study Completion: 2019-08-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Data collection	Data collection	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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.
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).

Trial Locations

Locations (8)

Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital; 🇬🇧 Dewsbury, United Kingdom

City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre; 🇬🇧 Sunderland, United Kingdom

Hull and East Yorkshire NHS Trust, Castle Hill Hospital; 🇬🇧 Cottingham, United Kingdom

University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital; 🇬🇧 Leicester, United Kingdom

Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital; 🇬🇧 Stoke-on-Trent, United Kingdom

South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital; 🇬🇧 Warwick, United Kingdom

Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation; 🇬🇧 Newcastle, United Kingdom

London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit; 🇬🇧 Harrow, United Kingdom