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The participants of this study will have AUL spasticity and have a need for botulinum toxin type A injections. AUL spasticity is where people develop tightening or stiffness of the muscles in the arms. Botulinum toxin type A is used for the treatment of spasticity in addition to physiotherapy. This study will ask participants to describe their experience living with AUL spasticity. This information will be used to assess the Arm Activity Measure (ArmA). ArmA is a scale designed to assess upper limb function in people with AUL spasticity. This study could suggest changes to the ArmA to improve its suitability for people with AUL spasticity or even the development of a new scale.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants answering to the questionnaire: for Part 1 15/15 subject | First interview/ at baseline |
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Inclusion Criteria :
Exclusion Criteria :
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The participants are at least 18 years old, able to read and communicate fluently in English and have a clinical diagnosis of spastic hemiparesis following stroke or traumatic brain injury (TBI). They must be at least 6 months post-stroke or TBI and have AUL in both arms that requires botulinum toxin type A injections as part of their AUL spasticity treatment.
Additionally, participants are required to be in a stable state regarding their therapeutic interventions (i.e., at least one month prior to assessment of eligibility) and have no other clinically relevant concerns that would hinder their ability to provide written informed consent and/or participate.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical, Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos National Rehab | Downey | California | 90242 | United States | ||
| MedStar National Rehabilitation Network |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |