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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03442660
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE December 15, 2017
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE May 25, 2018
Actual Primary Completion Date August 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
Validation of SQOL-6D in upper limb spasticity [ Time Frame: Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit) ]
Validity - Reliability - Responsiveness
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
  • EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels) [ Time Frame: Day 1 and then 8 weeks +/-2 ]
    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) [ Time Frame: Day 1 ]
    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) [ Time Frame: Day 1 and then 8 weeks +/-2 ]
    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) [ Time Frame: Day 1 and then 8 weeks +/-2 ]
    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 [ Time Frame: Day 1 and then 8 weeks +/-2 ]
    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 [ Time Frame: 8 weeks +/-2 ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of the Spasticity Related Quality of Life Questionnaire
Official Title  ICMJE Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Spasticity, Muscle
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Data collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2019)
104
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2018)
100
Actual Study Completion Date  ICMJE August 9, 2019
Actual Primary Completion Date August 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03442660
Other Study ID Numbers  ICMJE F-FR-52120-232
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP