Validation of the Spasticity Related Quality of Life Questionnaire

Spasticity, Muscle Clinical Trial

— SQOL-6D  

Official title:

Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442660
• Other study ID #: F-FR-52120-232
• Status: Completed
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: August 9, 2019

Study information

• Verified date: September 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Hull and East Yorkshire NHS Trust, Castle Hill Hospital	Cottingham
United Kingdom	Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital	Dewsbury
United Kingdom	London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit	Harrow
United Kingdom	University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital	Leicester
United Kingdom	Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation	Newcastle
United Kingdom	Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital	Stoke-on-Trent
United Kingdom	City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre	Sunderland
United Kingdom	South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital	Warwick

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of SQOL-6D in upper limb spasticity	Validity - Reliability - Responsiveness	Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)
Secondary	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
Secondary	Neurological Impairment Scale adapted for ULS (ULS-NIS)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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