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Trial record 37 of 720 for:    Botulinum Toxins, Type A

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

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ClinicalTrials.gov Identifier: NCT02469948
Recruitment Status : Unknown
Verified September 2015 by Chang Gung Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 12, 2015
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Drug: Botulinum toxin type A Phase 3

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:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Lower Extremities
Study Start Date : October 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox 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, 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, Electric stimulation and Surface anatomy landmark.
Other Name: Botulinum toxin




Primary Outcome Measures :
  1. 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 Measures :
  1. activities of daily living [ Time Frame: patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection ]
  2. Berg Balance Test [ Time Frame: patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection ]
  3. Tinetti Gait Analysis [ Time Frame: patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection ]
  4. Mini-Mental State Examination [ Time Frame: patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection ]
  5. Stroke Impact Scale [ Time Frame: patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection ]
  6. Fugl-Meyer Assessment Score [ Time Frame: patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection ]
  7. Functional Ambulation Classification [ Time Frame: patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection ]


Information from the National Library of Medicine

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

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): NCT02469948


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

Locations
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Taiwan
Chang Gung Memorial Hospital
Kaohsiung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Pong Ya-Ping, MD Rehabilitation

Publications:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02469948     History of Changes
Other Study ID Numbers: CMRPG8BC0781
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
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
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