Spasticity and Treatment Satisfaction Among Stroke Survivors

NCT ID: NCT03995524

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-20

Study Completion Date

2020-05-12

Brief Summary

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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

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Conditions

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Spasticity as Sequela of Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Ipsen Central Contact

Paris, , France

Site Status

Countries

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France

Other Identifiers

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F-FR-52120-258

Identifier Type: -

Identifier Source: org_study_id

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