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

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ClinicalTrials.gov Identifier: NCT02557737
Recruitment Status : Unknown
Verified March 2016 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2015
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Drug: Botulinum Toxin Type A Phase 3

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Surface Landmark, Ultrasonography and Electric Stimulation Guidance for Botulinum Toxin Injections in Stroke Patients With Spasticity on Upper Extremities.
Study Start Date : September 2012
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy Ultrasound

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 Name: 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 Name: 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 Name: Botulinum toxin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557737


Contacts
Contact: Pong Ya-Ping, MD 889-7-7317123 ext 6286 yaping0707@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Pong Ya-ping, MD    889-7-7317123 ext 6286    yaping0707@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Pong Ya-Ping, MD Rehabilitation

Publications:

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02557737     History of Changes
Other Study ID Numbers: CMRPG8B0222
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chang Gung Memorial Hospital:
stroke
upper extremity
spasticity
botulinum toxin
ultrasonography
electric stimulation

Additional relevant MeSH terms:
Muscle Spasticity
Stroke
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents