Spasticity as Sequela of StrokeREBOTNCT03995524
Spasticity and Treatment Satisfaction Among Stroke Survivors
An observational study of Spasticity as Sequela of Stroke, run by Ipsen at 1 site in France.
Trial summary
To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spasticity as Sequela of Stroke
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2019to 12 May 2020
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: 40 Adults subjects (male or female) suffering from post-stroke spasticity (the US, UK, France, and Italy), who are treated with BoNT-A in the course of routine clinical practice for focal spasticity
Who may be able to join
- Diagnostic of post-stroke spasticity more than three months prior to inclusion
- At least 6 months on treatment (or two treatment cycles) with BoNT-A injections for spasticity according to the decision of the physician
- Previous BoNT-A injection cycles did not last for more than 16 weeks
- Ambulatory (use of walking aids is acceptable)
Who cannot join
- Neurological disorder other than stroke
- Spasticity-specific treatment changes within 3 months prior to inclusion
- Patients who had undergone neurolysis or surgery to the affected limb within 6 months
- Concurrent participation in a clinical trial for the treatment of spasticity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perceived Spasticity and Treatment Satisfaction Among Stroke Survivors Over the Course of a Complete Treatment Cycle With Botulinum Neurotoxin A (BoNT-A): an Ethnographic Study.
To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle.
- Conditions
- Spasticity as Sequela of Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of functional limitations in daily life activities
Degree of functional limitations in daily life activities (i.e. physical functioning) associated with post-stroke spasticity as assessed by using WHODAS parameters, and identification of their characteristics and changes over time
Measured: monthly for 12 Weeks, or until end of injection cycle whichever occurs first
Health status in subjects with post-stroke spasticity
Health status in subjects with post-stroke spasticity as assessed by using EQ-5D-5L parameters, and identification of their characteristics and changes over time
Measured: weekly for 12 Weeks, or until end of injection cycle whichever occurs first
Severity of Pain
Severity of Pain as per EQ-5D-5L and a sliding scale. This is a descriptive scale that covers 5 dimensions: mobility, self-care, usual activities,pain/discomfort and anxiety/depression. the scale consist of 5 levels, where level one corresponds to "no problems" and level 5 corresponds to "extreme problem".
Measured: 12 weeks
Secondary outcomes (3)
Burden of spasticity/treatment
Themes/domains related to the everyday life experiences of subjects with post-stroke spasticity (e.g. burden disease/treatment) through qualitative analysis of in-depth open-ended interviews
Measured: Opening interview and ending qualitative interviews, ethnography data which will be provided at discretion of patient/caregiver for 12 weeks or duration of treatment, whichever occurs first, may also support these qualitative analyses
Patients' satisfaction
Subjects Report of Satisfaction with Treatment and their perception/desire of more tailored treatment options
Measured: weekly for 12 weeks or until end of injection cycle whichever occurs first. Opening and closing interview will also explore this
Comparison of feedback between caregivers and stroke survivors
Agreement between the themes elicited from semi-structured interviews between caregivers and subjects
Measured: opening ( before week 1) and ending ( 2 weeks after end of injection cycle) qualitative interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start20 Jul 2019
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity as Sequela of StrokeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT03995524
- Sponsor's protocol ID
- F-FR-52120-258
- Acronym
- REBOT
- Status last verified
- May 2020
- First submitted
- 29 May 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Spasticity and Treatment Satisfaction Among Stroke Survivors Over the Course of a Complete Treatment Cycle With Botulinum Neurotoxin A (BoNT-A): an Ethnographic Study.
- ClinicalTrials.gov ID
- NCT03995524
- Acronym / sponsor ID
- REBOT / F-FR-52120-258
- Conditions
- Spasticity as Sequela of Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 24 Jun 2019 (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.
To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 40 Adults subjects (male or female) suffering from post-stroke spasticity (the US, UK, France, and Italy), who are treated with BoNT-A in the course of routine clinical practice for focal spasticity
Key inclusion criteria (4 listed)
- Diagnostic of post-stroke spasticity more than three months prior to inclusion
- At least 6 months on treatment (or two treatment cycles) with BoNT-A injections for spasticity according to the decision of the physician
- Previous BoNT-A injection cycles did not last for more than 16 weeks
- Ambulatory (use of walking aids is acceptable)
Key exclusion criteria (4 listed)
- Neurological disorder other than stroke
- Spasticity-specific treatment changes within 3 months prior to inclusion
- Patients who had undergone neurolysis or surgery to the affected limb within 6 months
- Concurrent participation in a clinical trial for the treatment of spasticity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of functional limitations in daily life activities
Time frame: monthly for 12 Weeks, or until end of injection cycle whichever occurs first
Degree of functional limitations in daily life activities (i.e. physical functioning) associated with post-stroke spasticity as assessed by using WHODAS parameters, and identification of their characteristics and changes over time
Health status in subjects with post-stroke spasticity
Time frame: weekly for 12 Weeks, or until end of injection cycle whichever occurs first
Health status in subjects with post-stroke spasticity as assessed by using EQ-5D-5L parameters, and identification of their characteristics and changes over time
Severity of Pain
Time frame: 12 weeks
Severity of Pain as per EQ-5D-5L and a sliding scale. This is a descriptive scale that covers 5 dimensions: mobility, self-care, usual activities,pain/discomfort and anxiety/depression. the scale consist of 5 levels, where level one corresponds to "no problems" and level 5 corresponds to "extreme problem".
3 secondary outcomes
Burden of spasticity/treatment
Time frame: Opening interview and ending qualitative interviews, ethnography data which will be provided at discretion of patient/caregiver for 12 weeks or duration of treatment, whichever occurs first, may also support these qualitative analyses
Patients' satisfaction
Time frame: weekly for 12 weeks or until end of injection cycle whichever occurs first. Opening and closing interview will also explore this
Comparison of feedback between caregivers and stroke survivors
Time frame: opening ( before week 1) and ending ( 2 weeks after end of injection cycle) qualitative interviews
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 1 Jun 2020.
Related trials for Spasticity as Sequela of Stroke
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Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity as Sequela of Stroke, run by Ipsen at 1 site in France.
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 4 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 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Degree of functional limitations in daily life activities (time frame: monthly for 12 Weeks, or until end of injection cycle whichever occurs first). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2020.