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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 : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment Phase
Spasticity, Muscle Other: Data collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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).

  6. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442660


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

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03442660     History of Changes
Other Study ID Numbers: F-FR-52120-232
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms