Comparative Hybrid Effects of Combining BoNT-A With Robot-assisted or Mirror Therapy for U/E Spasticity Stroke Patients

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study will be to determine and compare the immediate and longer-term effects of combination of BoNT-A injection and mirror therapy vs combination of BoNT-A injection and robot-assisted therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Willing to provide written informed consent

• Clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months

• Upper limb spasticity (Modified Ashworth scale of ≥ 2)

• Moderate to severe movement impairment of U/E (FMA score ranging from 18 to 56)

• No serious cognitive impairment (i.e., Mini Mental State Exam score > 18)

• Age ≥ 18 years

Exclusion Criteria:

• Pregnant

• Bilateral hemispheric or cerebellar lesions

• Significant visual field deficits or hemineglect

• Contraindication for BoNT-A injection