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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Movement Disorders; Spasticity, Muscle; Stroke Sequelae
• Intervention / Treatment: Drug: Abobotulinum toxin A

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 Type: Observational
• Enrollment (Anticipated): 12

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Helena Bascuñana, Dr; Phone Number: +34 935537059; Email: hbascunana@santpau.cat
    • Contact: Eliot Ramirez, Dr; Phone Number: +34 935537059; Email: eramirezm@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Range of movement; Change in passive joint mobility (ROM) of the carpus (flexion-extension) affected by spasticity pattern III during a 20-week follow-up.	Drug: Abobotulinum toxin A; To measure ROM evolution in patients with post-stroke spasticity in the upper limb with spasticity pattern III.; Other Names: toxin infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (ACTUAL): December 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Spasticity; Injection; Abobotulinum toxin
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Movement Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: IIBSP-ROM-2020-135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No