Skip to main content
OpenTrials
Completed

NCT Number: NCT03442660

Validation of the Spasticity Related Quality of Life Questionnaire

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull and East Yorkshire NHS Trust, Castle Hill Hospital, Cottingham, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: SQOL-6D

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2018
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.