HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke

Recruiting

Phase 3 Results N/A

Trial Description

Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (or = 6 months).

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
Primary Box and blocks test
Primary Enjalbert test
Primary Modified Ashworth scale (upper limb)
Primary Functional Independence Measure
Primary Fugl-Meyer upper limb test
Primary Clinical Global Impression (CGI)
Primary 36-Item Short Form (SF-36) quality of life
Secondary Range of pain
Secondary Individual functional kinesitherapy

Sponsors