Validation of the Spasticity Related Quality of Life Questionnaire (SQOL-6D)

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

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.

Study Overview

• Status: Completed
• Conditions: Spasticity, Muscle
• Intervention / Treatment: Other: Data collection

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cottingham, United Kingdom, HU16 5JQ
    • Hull and East Yorkshire NHS Trust, Castle Hill Hospital
  • Dewsbury, United Kingdom, WF13 4HS
    • Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital
  • Harrow, United Kingdom, HA1 3UJ
    • London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit
  • Leicester, United Kingdom, LE5 4PW
    • University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital
  • Newcastle, United Kingdom, NE6 4QD
    • Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation
  • Stoke-on-Trent, United Kingdom, ST6 7AG
    • Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital
  • Sunderland, United Kingdom, SR4 7TP
    • City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre
  • Warwick, United Kingdom, CV34 6SR
    • South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Ipsen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2018
• Primary Completion (ACTUAL): August 9, 2019
• Study Completion (ACTUAL): August 9, 2019

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (ACTUAL): February 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: F-FR-52120-232

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No