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Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Lower 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 spasticity, botulinum toxin, ultrasonography guidance, electric stimulation guidance, stroke

Eligibility Criteria

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

Inclusion Criteria:

  • ankle varus spasticity with spasticity claw toes
  • MP joint and IP joint are above Modified Ashworth Scale 1 +
  • ankle varus spasticity and spasticity claw toes during walking should reach median level
  • patients feel pain or uncomfortable during walking due to spasticity claw toes.
  • patients never accept botox, phenol and alcohol injections before.

Exclusion Criteria:

  • contracture or deformity on lower extremity
  • combine other systemic disease of neurological or skelectomuscular system
  • patients accepted botox, phenol, alcohol injections and operation before.
  • cognition disorder or aphasia after stroke
  • Flexor Digitorum Longus, posterior tibialis and Flexor pollicis longus muscle has been significant atrophy .
  • systemic infection
  • under medication treatment of aminioglycoside or which can change neuromuskular transmission medicine
  • ankle plantarflxeor contracture during walking above median level or the sore of Modified Ashworth Scale is above 2 at rest
  • allergy to botox

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasonography direct-guidance

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 Surface anatomy landmark.

Outcomes

Primary Outcome Measures

Modified Ashworth scale

Secondary Outcome Measures

activities of daily living
Berg Balance Test
Tinetti Gait Analysis
Mini-Mental State Examination
Stroke Impact Scale
Fugl-Meyer Assessment Score
Functional Ambulation Classification

Full Information

First Posted
April 15, 2015
Last Updated
October 12, 2015
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02469948
Brief Title
Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Lower Extremities
Official Title
Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Lower Extremities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 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
Stroke may result in lower extremity spasticity, which interfere with motor voluntary function and activities of daily living. Botulinum toxin type A (BTX-A) has been shown to improve lower extremity spasticity of stroke patients. There are no researches to compare the efficiency of BTX-A injection by different guidance methods in the deep muscles of lower extremity for stroke patients. The aims of investigator's study were to compare the effectiveness of BTX-A injection by different guidance methods (palpation of anatomical landmarks, ultrasonography direct) in deep spastic muscles of lower extremity for stroke patients with varus spasticity and spastic claw toes , and to study the correlation between muscles spasticity and elastic properties by the sonoelastography/acoustic radiation force impulse imaging and follow the change of elastic properties in spastic muscles after BTX-A injection. We will enroll 80 hemiplegic stroke patients with varus spasticity / spastic claw toes and duration more than 6 months. Under different guidance methods (palpation of anatomical landmarks, electric stimulation, ultrasonography direct and indirect methods), BTX-A will be injected to the flexor digitorum longus and posterior tibialis muscles. If the patients have moderate hallucis spasticity, flexor hallucis longus muscle will be injected. The BTX-A dose is 50 units for each muscle. Outcome measures include Modified Ashworth Scale, Brunnstrom stage, muscle power, range of motion, the visual analog scale of pain, Stroke Impact Scale, Barthel index and lower extremity function tests, balance test, Goal Attainment Scale, sonoelastography and acoustic radiation force impulse imaging. All the assessments will be performed before BTX-A injection and followed up at 1 months, 2 months, 3 months and 6 months after injection. After performing all the assessments, investigator will investigate the efficiency of BTX-A by different guidance methods.
Detailed Description
Stroke may result in lower extremity spasticity, which interfere with motor voluntary function and activities of daily living. Botulinum toxin type A (BTX-A) has been shown to improve lower extremity spasticity of stroke patients. There are no researches to compare the efficiency of BTX-A injection by different guidance methods in the deep muscles of lower extremity for stroke patients. The aims of investigator's study were to compare the effectiveness of BTX-A injection by different guidance methods (palpation of anatomical landmarks, electric stimulation, ultrasonography direct and indirect methods) in deep spastic muscles of lower extremity for stroke patients with varus spasticity and spastic claw toes , and to study the correlation between muscles spasticity and elastic properties by the sonoelastography/acoustic radiation force impulse imaging and follow the change of elastic properties in spastic muscles after BTX-A injection. We will enroll 80 hemiplegic stroke patients with varus spasticity / spastic claw toes and duration more than 6 months. Under different guidance methods (palpation of anatomical landmarks, electric stimulation, ultrasonography direct and indirect methods), BTX-A will be injected to the flexor digitorum longus and posterior tibialis muscles. If the patients have moderate hallucis spasticity, flexor hallucis longus muscle will be injected. The BTX-A dose is 50 units for each muscle. Outcome measures include Modified Ashworth Scale, Brunnstrom stage, muscle power, range of motion, the visual analog scale of pain, Stroke Impact Scale, Barthel index and lower extremity function tests, balance test, Goal Attainment Scale, sonoelastography and acoustic radiation force impulse imaging. All the assessments will be performed before BTX-A injection and followed up at 1 months, 2 months, 3 months and 6 months after injection. After performing all the assessments, investigator will investigate the efficiency of BTX-A by different guidance methods. Two of arms: ultrasonography direct-guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-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
spasticity, botulinum toxin, ultrasonography guidance, electric stimulation guidance, stroke

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
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, Electric stimulation and Surface anatomy landmark.
Primary Outcome Measure Information:
Title
Modified Ashworth scale
Time Frame
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Secondary Outcome Measure Information:
Title
activities of daily living
Time Frame
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Title
Berg Balance Test
Time Frame
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Title
Tinetti Gait Analysis
Time Frame
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Title
Mini-Mental State Examination
Time Frame
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Title
Stroke Impact Scale
Time Frame
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Title
Fugl-Meyer Assessment Score
Time Frame
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Title
Functional Ambulation Classification
Time Frame
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ankle varus spasticity with spasticity claw toes MP joint and IP joint are above Modified Ashworth Scale 1 + ankle varus spasticity and spasticity claw toes during walking should reach median level patients feel pain or uncomfortable during walking due to spasticity claw toes. patients never accept botox, phenol and alcohol injections before. Exclusion Criteria: contracture or deformity on lower extremity combine other systemic disease of neurological or skelectomuscular system patients accepted botox, phenol, alcohol injections and operation before. cognition disorder or aphasia after stroke Flexor Digitorum Longus, posterior tibialis and Flexor pollicis longus muscle has been significant atrophy . systemic infection under medication treatment of aminioglycoside or which can change neuromuskular transmission medicine ankle plantarflxeor contracture during walking above median level or the sore of Modified Ashworth Scale is above 2 at rest allergy to botox
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

12. IPD Sharing Statement

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

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