Spasticity and Treatment Satisfaction Among Stroke Survivors (REBOT)

Ipsen

Status: Completed

Conditions: Spasticity as Sequela of Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT03995524

F-FR-52120-258

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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