Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities

March 28, 2016 updated by: Chang Gung Memorial Hospital

Comparison of Surface Landmark, Ultrasonography and Electric Stimulation Guidance for Botulinum Toxin Injections in Stroke Patients With Spasticity on Upper Extremities.

The aims of this study were to compare the injection locations of key spastic muscles on upper extremity by three different guidance localization methods ( surface anatomy landmark, ultrasonography, electric stimulation) and the effectiveness.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Stroke may result in acute or chronic hemiplegia and spasticity in stroke patients. Spasticity in upper extremities may interfere with motor voluntary function, activities of daily living and cause muscle pain. Botulinum toxin type A (BTX-A) has been shown to relieve spasticity and pain in upper extremities of stroke patients. There are no researches to compare the efficiency of BTX-A by different injection guidance methods in stroke patients. The aims of our study were to compare the injection locations of key spastic muscles on upper extremity by three different guidance localization methods ( surface anatomy landmark, ultrasonography, electric stimulation) and the effectiveness. The investigators will enroll 60 hemiplegic stroke patients with upper extremity spasticity more than modified Ashworth scale ( MAS) 1+ and duration more than 6 months. Under different guidance methods (surface anatomy landmark/ ultrasonography /electric stimulation ), BTX-A will be injected to the key spastic muscles on upper extremity. Outcome measures include MAS, motor function ( Brunnstrom stage of upper extremity), range of motion , the degree and visual analog scale of pain , pinch and grasp power，Stroke Impact Scale, Barthel index and upper extremity function (Nine hole peg test，Action Reaearch Arm Test，Wolf Motor Function test，Chedoke Arm and Han Activity Inventory，Fugl-Meyer Assessment Scale，Motor Activity Log). All the assessments will be performed before BTX-A injection and followed up at 4 weeks, 8 weeks, 12 weeks and 24 weeks after injection. After performing all the assessments, investigators will investigate the efficiency of BTX-A by different guidance methods.

Four of arms:

ultrasonography direct-guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.

ultrasonography indirect-guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography indirect-guidance.

electric stimulation guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by electric stimulation guidance.

surface anatomy landmark: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by surface anatomy landmark.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first onset.
  • at least onset before 6 months.
  • elbow, wrist and fingers are above Modified Ashworth Scale(MAS) 1+.
  • Mini-Mental State Exam above 24.
  • can follow all of the follow up and instruction.
  • patients never accept botox, phenol and alcohol injections before.

Exclusion Criteria:

  • contracture deformity on upper extremity.
  • patients had accepted botox before or had have phenol, alcohol injections and operation 6 months ago.
  • allergy to botox.
  • have neither infection nor skin disorder on inject site.
  • now accept aminoglycoside or other medicine treatment which may affect neuromuscular transition.
  • combine other systemic disease of neurological or skelectomuscular system
  • cognition disorder or aphasia after stroke.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasonography direct-guidance
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.
Drug: Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.
Other Names:
  • Botulinum toxin
Active Comparator: Surface anatomy landmark
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Surface anatomy landmark.
Drug: Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.
Other Names:
  • Botulinum toxin
Experimental: Electric stimulation
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation
Drug: Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.
Other Names:
  • Botulinum toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale
Time Frame: Change from Baseline Muscle Tone at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Muscle Tone at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brunnstrome Stage
Time Frame: Change from Baseline Condition at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Condition at 6 months
Active Range of Motion
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
4 Point Categorical Pain Intensity Scale
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Hand-grasp strength Assessment
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Pinch Strength Assessment
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Barthel Index
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Stroke Impact Scale (SIS)
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Action Research Arm Test (ARAT)
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Wolf Motor Function Test
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Chedoke Arm and Hand Activity Inventory (CAHAI)
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Fugl-Meyer Assessment
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Motor Activity Log Scale
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months
Nine Hole Peg Test
Time Frame: Change from Baseline Data at 6 months
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Change from Baseline Data at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8B0222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebrovascular Accident

Clinical Trials on Botulinum Toxin Type A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe