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Status:

COMPLETED

Early Treatment of Post-stroke Spasticity With Botulinum Toxin

Lead Sponsor:

Universita di Verona

Conditions:

Stroke

Eligibility:

All Genders

18+ years

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 enroll...

Detailed Description

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 centres involve...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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

Key Trial Info

Start Date :

July 27 2015

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2018

Estimated Enrollment :

86 Patients enrolled

Trial Details

Trial ID

NCT04404868

Start Date

July 27 2015

End Date

December 31 2018

Last Update

May 28 2020

Active Locations (1)

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1

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

Verona, Italy, 37124