Valuation of the Evolution of Passive Mobility in the Spastic Upper Limb After Injection of Abobotulinumtoxin(Dysport®)

• Conditions: Movement Disorders; Stroke Sequelae; Spasticity, Muscle
• Interventions: Drug: Abobotulinum toxin A

• Registration Number: NCT05151874
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

Assessing the objective measurement of passive joint mobility (ROM) in the spastic upper limb with Jost's pattern III in patients with post-stroke spasticity after infiltration with BoNT-A allows to objectify the increase in passive joint balance (ROM).

Detailed Description

Changes in joint mobility in patients with post-stroke upper limb spasticity after infiltration of botulinum toxin type A.

The spasticity pattern that will be evaluated will be pattern number III based on the classification of Jost et al. Joint mobility will be measured with the Lynx instrument (DyCare)

Study Timeline

• Study First Submitted: 2021-08-06
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-26
• Last Update Submitted: 2021-11-26
• Study First Posted: 2021-12-09
• Last Update Posted: 2021-12-09
• Study Start: 2022-01
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients aged ≥ 18 years.
• Hemiplegic patients with post-stroke upper limb spasticity affected by pattern III1 who have undergone at least 2 cycles of previous treatment with BoNT-A
• Patients with a MAS scale (Modified Ashworth Scale) between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
• Patients with Hackett ultrasound qualitative scale between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.

Exclusion Criteria

• Patients who do not wish to sign the informed consent.
• Prior lack of primary or secondary response to any BoNT-A for any specific condition or known sensitivity to BoNT-A or any excipient.
• Routine or prescribed treatment with any medication that directly or indirectly interferes with neuromuscular function in the last 3 months prior to study botulinum toxin treatment.
• Having undergone surgery on the muscles, ligaments, tendons, nerves or bones of the limb to be treated.
• Any medical condition or analytical finding that, in the opinion of the investigator, may compromise compliance with the objectives and / or procedures of the study protocol or exclude the administration of BoNT-A.
• Treatment with an investigational new drug in the 4 weeks or 5 half-lives prior to screening to enter the study.
• Pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Range of movement	Abobotulinum toxin A	Change in passive joint mobility (ROM) of the carpus (flexion-extension) affected by spasticity pattern III during a 20-week follow-up.

Primary Outcome Measures

Name	Time	Method
Change in passive range of motion	Through study completion, an average of 1 year	Change in passive joint mobility (ROM) of the upper limb affected by spasticity pattern III a 20-week follow-up.

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain