Back to resultsValidation of the Spasticity Related Quality of Life Questionnaire (SQOL-6D)
Primary Purpose
Spasticity, Muscle
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Data collection
Sponsored by
About this trial
This is an interventional other trial for Spasticity, Muscle
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
Sites / Locations
- Hull and East Yorkshire NHS Trust, Castle Hill Hospital
- Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital
- London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit
- University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital
- Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation
- Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital
- City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre
- South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Data collection
Arm Description
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.
Outcomes
Primary Outcome Measures
Validation of SQOL-6D in upper limb spasticity
Validity - Reliability - Responsiveness
Secondary Outcome Measures
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.
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).
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).
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.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03442660
Brief Title
Validation of the Spasticity Related Quality of Life Questionnaire
Acronym
SQOL-6D
Official Title
Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
August 9, 2019 (Actual)
Study Completion Date
August 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity, Muscle
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Data collection
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Data collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Validation of SQOL-6D in upper limb spasticity
Description
Validity - Reliability - Responsiveness
Time Frame
Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)
Secondary Outcome Measure Information:
Title
EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels)
Description
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
Title
Neurological Impairment Scale adapted for ULS (ULS-NIS)
Description
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
Title
Modified Ashworth Scale (MAS)
Description
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
Title
Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity)
Description
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
Title
ArmA (Arm Activity Measure) Scores
Description
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).
Time Frame
Day 1 and then 8 weeks +/-2
Title
Global assessment of benefit
Description
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).
Time Frame
8 weeks +/-2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Hull and East Yorkshire NHS Trust, Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital
City
Dewsbury
ZIP/Postal Code
WF13 4HS
Country
United Kingdom
Facility Name
London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation
City
Newcastle
ZIP/Postal Code
NE6 4QD
Country
United Kingdom
Facility Name
Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital
City
Stoke-on-Trent
ZIP/Postal Code
ST6 7AG
Country
United Kingdom
Facility Name
City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Facility Name
South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital
City
Warwick
ZIP/Postal Code
CV34 6SR
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34726763
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.
Results Reference
derived
Learn more about this trial
Validation of the Spasticity Related Quality of Life Questionnaire
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