Validation of the Spasticity Related Quality of Life Questionnaire

Ipsen104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

104

Conditions

Spasticity, Muscle

Interventions

Data collectionOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

Validation of SQOL-6D in upper limb spasticity

Validity - Reliability - Responsiveness

Time frame: Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)

Secondary Outcomes

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.

Time frame: Day 1 and then 8 weeks +/-2

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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.