Spasticity, MuscleSQOL-6DNCT03442660
Validation of the Spasticity Related Quality of Life Questionnaire
A study testing Data collection in people with Spasticity, Muscle, run by Ipsen at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Muscle
- What is being tested?
- Data collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 25 May 2018to 9 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Hull and East Yorkshire NHS Trust, Castle Hill Hospital
Cottingham, HU16 5JQ
Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital
Dewsbury, WF13 4HS
London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit
Harrow, HA1 3UJ
University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital
Leicester, LE5 4PW
Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation
Newcastle, NE6 4QD
Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital
Stoke-on-Trent, ST6 7AG
City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre
Sunderland, SR4 7TP
South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital
Warwick, CV34 6SR
About this study
Official title: Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity
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.
Read the 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.
- Conditions
- Spasticity, Muscle
- Being tested
- Data collection
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of SQOL-6D in upper limb spasticity
Validity - Reliability - Responsiveness
Measured: Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)
Secondary outcomes (6)
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.
Measured: Day 1 and then 8 weeks +/-2
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).
Measured: Day 1
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).
Measured: Day 1 and then 8 weeks +/-2
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.
Measured: Day 1 and then 8 weeks +/-2
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).
Measured: Day 1 and then 8 weeks +/-2
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).
Measured: 8 weeks +/-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start25 May 2018
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442660
- Sponsor's protocol ID
- F-FR-52120-232
- Acronym
- SQOL-6D
- Status last verified
- Sep 2019
- First submitted
- 15 Dec 2017
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34726763
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity
- ClinicalTrials.gov ID
- NCT03442660
- Acronym / sponsor ID
- SQOL-6D / F-FR-52120-232
- Conditions
- Spasticity, Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 25 May 2018 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection | Other | Other: Data collectionAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionSubjects 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. | Other | Data collection |
Primary outcome
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
6 secondary outcomes
EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels)
Time frame: Day 1 and then 8 weeks +/-2
Neurological Impairment Scale adapted for ULS (ULS-NIS)
Time frame: Day 1
Modified Ashworth Scale (MAS)
Time frame: Day 1 and then 8 weeks +/-2
Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity)
Time frame: Day 1 and then 8 weeks +/-2
ArmA (Arm Activity Measure) Scores
Time frame: Day 1 and then 8 weeks +/-2
Global assessment of benefit
Time frame: 8 weeks +/-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Derived from this study: PubMed 34726763Turner-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection in people with Spasticity, Muscle, run by Ipsen at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of SQOL-6D in upper limb spasticity (time frame: Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03442660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.