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

Primary Purpose

Cerebrovascular Accident

Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring stroke, upper extremity, spasticity, botulinum toxin, ultrasonography, electric stimulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Ultrasonography direct-guidance

Electric stimulation

Surface anatomy landmark

Arm Description

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

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation

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

Outcomes

Primary Outcome Measures

Modified Ashworth Scale
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection

Secondary Outcome Measures

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

Full Information

First Posted
September 17, 2015
Last Updated
March 28, 2016
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02557737
Brief Title
Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities
Official Title
Comparison of Surface Landmark, Ultrasonography and Electric Stimulation Guidance for Botulinum Toxin Injections in Stroke Patients With Spasticity on Upper Extremities.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
stroke, upper extremity, spasticity, botulinum toxin, ultrasonography, electric stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasonography direct-guidance
Arm Type
Experimental
Arm Description
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.
Arm Title
Electric stimulation
Arm Type
Experimental
Arm Description
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation
Arm Title
Surface anatomy landmark
Arm Type
Active Comparator
Arm Description
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Surface anatomy landmark.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Botulinum toxin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Muscle Tone at 6 months
Secondary Outcome Measure Information:
Title
Brunnstrome Stage
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Condition at 6 months
Title
Active Range of Motion
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
4 Point Categorical Pain Intensity Scale
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Hand-grasp strength Assessment
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Pinch Strength Assessment
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Barthel Index
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Stroke Impact Scale (SIS)
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Action Research Arm Test (ARAT)
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Wolf Motor Function Test
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Chedoke Arm and Hand Activity Inventory (CAHAI)
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Fugl-Meyer Assessment
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Motor Activity Log Scale
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months
Title
Nine Hole Peg Test
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time Frame
Change from Baseline Data at 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pong Ya-Ping, MD
Phone
889-7-7317123
Ext
6286
Email
yaping0707@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pong Ya-Ping, MD
Organizational Affiliation
Rehabilitation
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pong Ya-ping, MD
Phone
889-7-7317123
Ext
6286
Email
yaping0707@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities

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