Clinical trial NCT03442660: Validation of the Spasticity Related Quality of Life Questionnaire
Official title: Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity, Muscle
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of SQOL-6D in upper limb spasticity
timeFrame: Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)
Secondary outcomes:
measure: EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels)
timeFrame: Day 1 and then 8 weeks +/-2
measure: Neurological Impairment Scale adapted for ULS (ULS-NIS)
timeFrame: Day 1
measure: Modified Ashworth Scale (MAS)
timeFrame: Day 1 and then 8 weeks +/-2
measure: Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity)
timeFrame: Day 1 and then 8 weeks +/-2
measure: ArmA (Arm Activity Measure) Scores
timeFrame: Day 1 and then 8 weeks +/-2
measure: Global assessment of benefit
timeFrame: 8 weeks +/-2
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Hull and East Yorkshire NHS Trust, Castle Hill Hospital
city: Dewsbury
country: United Kingdom
facility: Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital
city: Harrow
country: United Kingdom
facility: London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital
city: Newcastle
country: United Kingdom
facility: Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation
city: Stoke-on-Trent
country: United Kingdom
facility: Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital
city: Sunderland
country: United Kingdom
facility: City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre
city: Warwick
country: United Kingdom
facility: South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.