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

NCT05151874 | Unknown

• 1 other identifier: IIBSP-ROM-2020-135
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Spasticity, Muscle; Stroke Sequelae; Movement Disorders

Keywords

Spasticity; Abobotulinum toxin; Injection; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Abobotulinum toxin A DRUG

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

Also known as: toxin infiltration

Range of movement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Muscle Spasticity; Movement Disorders

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: December 9, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

ES (1)