Early Treatment of Post-stroke Spasticity With Botulinum Toxin

NCT04404868 | Completed

• 1 other identifier: BoNT-A early treatment
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This was a multicentric observational study with the aim to evaluate the effect of early treatment with botulinum toxin type A (BoNT-A) on post-stroke spasticity in adult patients. All patients enrolled (86 patients) after a baseline clinical assessment (modified Ashworth scale, motricity index, Fughl Meyer assessment and modified Rankin' scale) undergoes to a BoNT-A injection following the evidence-based clinical practice. Subsequently, at 4, 12 and 24 weeks they underwent the same clinical evaluation as a follow-up. Results are under statistical evaluation.

Conditions

Stroke

Keywords

Stroke; Botulinum toxin; Spasticity

Outcome Measures

Primary Outcomes (1)

• Time elapsed

  In order to evaluate the role of the time elapsed since the acute event on the therapeutic efficacy of the first administration of BoNT-A, the reduction of spastic hypertonia will be considered as the primary endpoint. Patients who gain a reduction of at least 1 point at the modified Ashworth scale (MAS) were defined as "responder". Who did not achieve that amelioration was classified as "non-responders".

  T1 (4 weeks)

Secondary Outcomes (4)

• Modified Ashworth scale (MAS)

  T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)

• Motricity index (MI)

  T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)

• Fughl Meyer assessment (FMA)

  T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)

• Modified rankin scale (MRS)

  T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)

Study Arms (1)

Enrolled patients

Each patient (whether hospitalized or outpatient) included in the study underwent to a baseline evaluation in which near and remote pathological history were recorded (main concomitant pathologies, drug therapy in progress, previous major surgery) and the following evaluation scales were administered: modified Ashworth scale (MAS), MI (motricity index), FMA (Fughl Meyer assessment) and Modified Rankin' scale (MRS). Each patient will subsequently undergo to a follow-up evaluation at 4, 12 and 24 weeks after the date of inoculation through the execution of a specialist visit (physiatric/neurological) and the administration of the following evaluation scales: MAS, MI, FMA and MRS. For the duration of the study, each patient may undergo integrated rehabilitation treatment at the discretion of each of the investigators of each centre involved in the study according to the guidelines and common clinical practice.

Other: Normal clinical practice

Interventions

Normal clinical practice OTHER

There are no experimental interventions. The procedures are in line with normal clinical practice.

Enrolled patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with the occurrence of post-stroke spastic hypertonia involving the main muscle groups of the affected side.

You may qualify if:

• Diagnosis of spasticity as a consequence of cerebral stroke (ischemic or hemorrhagic) documented radiologically by brain CT or MRI;
• Presence of spastic hypertonia in the main muscle groups of the affected side with an intensity equal to or greater than MAS 1+/4;
• Presence of paresis in the affected side with weakness of the main muscle groups equal to or less than 2 according to the MRC scale;
• Time elapsed since cerebral stroke less than 12 months;
• No prior focal treatment of spasticity with botulinum toxin.

You may not qualify if:

• Participation in other ongoing clinical studies
• Presence of joint limitation or muscle contractures to the main muscle groups of the affected side quantifiable as a score of 4/4 at the MAS
• Therapy with antispastic drugs (baclofen, dantrolene, tizanidine, benzodiazepines, clonidine, phenothiazine)
• Other neurological (previous cerebral strokes, Parkinson's disease, multiple sclerosis, medullary pathologies, extrapyramidal syndromes) or orthopaedic (severe osteoarthritis, previous arthroplasty with residual joint limitation or fracture healed with angular defects) diseases involving the affected side and able to influence the results of the study.
• Particularly vulnerable populations
• The following cannot be included in the study:
• women of childbearing age who do not use contraceptives
• pregnant women
• women in the breastfeeding period
• patients in an emergency situation
• Criteria for anticipated exit from the study:
• Relapse of disease during the study period
• Withdrawal of informed consent to participate in the study
• Inability to perform the first follow-up evaluation 4 weeks after BoNT-A administration

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy

Verona, 37124, Italy

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicola Smania, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 28, 2020
• Study Start: July 27, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

IT (1)