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

Movement Disorders Clinical Trial

— ROM-ICTUS  

Official title:

Valuation of the Evolution of Passive Mobility (ROM)in the Spastic Upper Limb After Injection of Abobotulinumtoxin(Dysport®) in Patients With Post-stroke Spasticity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05151874
• Other study ID #: IIBSP-ROM-2020-135
• Status: Not yet recruiting
• Start date: January 2022
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Movement Disorders
• Muscle Spasticity
• Spasticity, Muscle
• Stroke Sequelae

Intervention

Drug:
• Abobotulinum toxin A
To measure ROM evolution in patients with post-stroke spasticity in the upper limb with spasticity pattern III.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in passive range of motion	Change in passive joint mobility (ROM) of the upper limb affected by spasticity pattern III a 20-week follow-up.	Through study completion, an average of 1 year