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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05151874
Acronym
ROM-ICTUS
Enrollment
12
Registered
2021-12-09
Start date
2022-01-31
Completion date
2022-12-31
Last updated
2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Movement Disorders, Spasticity, Muscle, Stroke Sequelae

Keywords

Spasticity, Abobotulinum toxin, Injection, Rehabilitation

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)

Interventions

To measure ROM evolution in patients with post-stroke spasticity in the upper limb with spasticity pattern III.

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in passive range of motionThrough study completion, an average of 1 yearChange in passive joint mobility (ROM) of the upper limb affected by spasticity pattern III a 20-week follow-up.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026