CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 37 enrolled
Drug / intervention
Botulinum Toxin Type A +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02749591
NCT02749591Phase 3Completed

Comparative Hybrid Effects of Combining Botulinum Toxin Type A With Robot-assisted Training v.s. With Mirror Therapy for Stroke Patients With Upper Extremity Spasticity: A Randomized Controlled Study

Chang Gung Memorial Hospital·interventional·Posted Apr 25, 2016·Updated Jul 18, 2018

In Brief

A Phase 3 clinical trial evaluating Botulinum Toxin Type A, Robot-assisted therapy, and 2 other interventions for Stroke. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesTaiwan
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 25, 2016
Enrollment StartMay 2, 2016
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.2 years ago

Interventions

Botulinum Toxin Type Adrug

To inject Botulinum toxin type A on the spasticity upper extremity for stroke patients.Doses and muscles selected for BoNT-A injection are individualized on the basis of a number of factors, including the spasticity patterns, severity of spasticity, and treatment goals

Robot-assisted therapyother

After injecting Botulinum toxin type A on the spasticity upper extremity, the RT group will receive a 45 minutes of robotic training and 30 minutes of training in functional training.

Mirror therapyother

After injecting Botulinum toxin type A on the spasticity upper extremity, the MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training.

Control interventionother

After injecting Botulinum toxin type A on the spasticity upper extremity, the CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.