Validation of the Spasticity Related Quality of Life Questionnaire

NCT03442660 | Completed

• 1 other identifier: F-FR-52120-232
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 8

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.

Conditions

Spasticity, Muscle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels)

  Day 1 and then 8 weeks +/-2

• Neurological Impairment Scale adapted for ULS (ULS-NIS)

  Day 1

• Modified Ashworth Scale (MAS)

  Day 1 and then 8 weeks +/-2

• Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity)

  Day 1 and then 8 weeks +/-2

• ArmA (Arm Activity Measure) Scores

  Day 1 and then 8 weeks +/-2

Study Arms (1)

Data collection

OTHER

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

Interventions

Data collection OTHER

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.

Data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (8)

Hull and East Yorkshire NHS Trust, Castle Hill Hospital

Cottingham, HU16 5JQ, United Kingdom

Location

Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital

Dewsbury, WF13 4HS, United Kingdom

Location

London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit

Harrow, HA1 3UJ, United Kingdom

Location

University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

Location

Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation

Newcastle, NE6 4QD, United Kingdom

Location

Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital

Stoke-on-Trent, ST6 7AG, United Kingdom

Location

City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre

Sunderland, SR4 7TP, United Kingdom

Location

South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital

Warwick, CV34 6SR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34726763 DERIVED

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: February 22, 2018
• Study Start: May 25, 2018
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

GB (8)