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

NCT02749591 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-07-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Botulinum Toxin Type A

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

OTHER

Robot-assisted therapy

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.

OTHER

Mirror therapy

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.

OTHER

Control intervention

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Jen-Wen Hung · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-02
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02749591 on ClinicalTrials.gov