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

NCT02469948 | Unknown Phase 3

• 1 other identifier: CMRPG8BC0781
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

spasticity; botulinum toxin; ultrasonography guidance; electric stimulation guidance; stroke

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth scale

  patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection

Secondary Outcomes (7)

• activities of daily living

  patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection

• Berg Balance Test

  patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection

• Tinetti Gait Analysis

  patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection

• Mini-Mental State Examination

  patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection

• Stroke Impact Scale

  patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection

Study Arms (2)

Ultrasonography direct-guidance

EXPERIMENTAL

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

Drug: Botulinum toxin type A

Surface anatomy landmark

ACTIVE COMPARATOR

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

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.

Also known as: Botulinum toxin

Surface anatomy landmark; Ultrasonography direct-guidance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (13)

• Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.

  PMID: 18164331 BACKGROUND

• Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.

  PMID: 18635841 BACKGROUND

• Wissel J, Ward AB, Erztgaard P, Bensmail D, Hecht MJ, Lejeune TM, Schnider P, Altavista MC, Cavazza S, Deltombe T, Duarte E, Geurts AC, Gracies JM, Haboubi NH, Juan FJ, Kasch H, Katterer C, Kirazli Y, Manganotti P, Parman Y, Paternostro-Sluga T, Petropoulou K, Prempeh R, Rousseaux M, Slawek J, Tieranta N. European consensus table on the use of botulinum toxin type A in adult spasticity. J Rehabil Med. 2009 Jan;41(1):13-25. doi: 10.2340/16501977-0303.

  PMID: 19197564 BACKGROUND

• Chin TY, Nattrass GR, Selber P, Graham HK. Accuracy of intramuscular injection of botulinum toxin A in juvenile cerebral palsy: a comparison between manual needle placement and placement guided by electrical stimulation. J Pediatr Orthop. 2005 May-Jun;25(3):286-91. doi: 10.1097/01.bpo.0000150819.72608.86.

  PMID: 15832139 BACKGROUND

• Molloy FM, Shill HA, Kaelin-Lang A, Karp BI. Accuracy of muscle localization without EMG: implications for treatment of limb dystonia. Neurology. 2002 Mar 12;58(5):805-7. doi: 10.1212/wnl.58.5.805.

  PMID: 11889247 BACKGROUND

• Yang EJ, Rha DW, Yoo JK, Park ES. Accuracy of manual needle placement for gastrocnemius muscle in children with cerebral palsy checked against ultrasonography. Arch Phys Med Rehabil. 2009 May;90(5):741-4. doi: 10.1016/j.apmr.2008.10.025.

  PMID: 19406292 BACKGROUND

• O'Brien CF. Injection techniques for botulinum toxin using electromyography and electrical stimulation. Muscle Nerve Suppl. 1997;6:S176-80.

  PMID: 9826989 BACKGROUND

• Berweck S, Schroeder AS, Fietzek UM, Heinen F. Sonography-guided injection of botulinum toxin in children with cerebral palsy. Lancet. 2004 Jan 17;363(9404):249-50. doi: 10.1016/S0140-6736(03)15351-2. No abstract available.

  PMID: 14738817 BACKGROUND

• Schroeder AS, Berweck S, Lee SH, Heinen F. Botulinum toxin treatment of children with cerebral palsy - a short review of different injection techniques. Neurotox Res. 2006 Apr;9(2-3):189-96. doi: 10.1007/BF03033938.

  PMID: 16785117 BACKGROUND

• Picelli A, Bonetti P, Fontana C, Barausse M, Dambruoso F, Gajofatto F, Tamburin S, Girardi P, Gimigliano R, Smania N. Accuracy of botulinum toxin type A injection into the gastrocnemius muscle of adults with spastic equinus: manual needle placement and electrical stimulation guidance compared using ultrasonography. J Rehabil Med. 2012 May;44(5):450-2. doi: 10.2340/16501977-0970.

  PMID: 22549655 BACKGROUND

• Picelli A, Tamburin S, Bonetti P, Fontana C, Barausse M, Dambruoso F, Gajofatto F, Santilli V, Smania N. Botulinum toxin type A injection into the gastrocnemius muscle for spastic equinus in adults with stroke: a randomized controlled trial comparing manual needle placement, electrical stimulation and ultrasonography-guided injection techniques. Am J Phys Med Rehabil. 2012 Nov;91(11):957-64. doi: 10.1097/PHM.0b013e318269d7f3.

  PMID: 23085706 BACKGROUND

• Lim EC, Ong BK, Seet RC. Botulinum toxin-A injections for spastic toe clawing. Parkinsonism Relat Disord. 2006 Jan;12(1):43-7. doi: 10.1016/j.parkreldis.2005.06.008. Epub 2005 Sep 29.

  PMID: 16198612 BACKGROUND

• Suputtitada A. Local botulinum toxin type A injections in the treatment of spastic toes. Am J Phys Med Rehabil. 2002 Oct;81(10):770-5. doi: 10.1097/00002060-200210000-00009.

  PMID: 12362118 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Botulinum Toxins, Type A; Botulinum Toxins

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Pong Ya-Ping, MD

  Rehabilitation

  STUDY CHAIR

Central Study Contacts

Pong Ya-Ping, MD

CONTACT

889-7-7317123; yaping0707@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: June 12, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 14, 2015

Record last verified: 2015-09

Locations

TW (1)