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出境医 / 临床实验 / Spasticity and Treatment Satisfaction Among Stroke Survivors (REBOT)
Spasticity and Treatment Satisfaction Among Stroke Survivors (REBOT)
Study Description
Brief 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.
| Condition or disease |
|---|
| Spasticity as Sequela of Stroke |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 30 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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. |
| Actual Study Start Date : | July 20, 2019 |
| Actual Primary Completion Date : | May 12, 2020 |
| Actual Study Completion Date : | May 12, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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".
Secondary Outcome Measures :
- 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 ]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
- 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 ]Subjects Report of Satisfaction with Treatment and their perception/desire of more tailored treatment options
- 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 ]Agreement between the themes elicited from semi-structured interviews between caregivers and subjects
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
Locations
| France | |
| Ipsen Central Contact | |
| Paris, France | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 29, 2019 | ||||
| First Posted Date | June 24, 2019 | ||||
| Last Update Posted Date | June 1, 2020 | ||||
| Actual Study Start Date | July 20, 2019 | ||||
| Actual Primary Completion Date | May 12, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Spasticity and Treatment Satisfaction Among Stroke Survivors | ||||
| 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. | ||||
| Brief 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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 | ||||
| Condition | Spasticity as Sequela of Stroke | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
30 | ||||
| Original Estimated Enrollment |
40 | ||||
| Actual Study Completion Date | May 12, 2020 | ||||
| Actual Primary Completion Date | May 12, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03995524 | ||||
| Other Study ID Numbers | F-FR-52120-258 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Ipsen | ||||
| Study Sponsor | Ipsen | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Ipsen | ||||
| Verification Date | May 2020 | ||||
