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Cerebrovascular AccidentPhase 3NCT02557737

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

A Phase 3 study testing Botulinum Toxin Type A in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cerebrovascular Accident
What is being tested?
Botulinum Toxin Type A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTaiwan
Study dates
Sep 2012to Jul 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pong Ya-Ping, MD contact

889-7-7317123 ext. 6286

yaping0707@gmail.com

Taiwan1 site, 1 recruiting

  • Chang Gung Memorial Hospital

    Kaohsiung City

    Pong Ya-ping, MD, 889-7-7317123 ext. 6286, yaping0707@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Comparison of Surface Landmark, Ultrasonography and Electric Stimulation Guidance for Botulinum Toxin Injections in Stroke Patients With Spasticity on Upper Extremities.

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.

Read the 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.

Keywords
stroke, upper extremity, spasticity, botulinum toxin, ultrasonography, electric stimulation
Medical subject headings
Stroke, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum Toxin Type ADrug

    Also called Botulinum toxin

    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.

Study groups in NCT02557737
Study groupRoleWhat they receive
Ultrasonography direct-guidanceExperimentalTo inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.
Receives: Drug: Botulinum Toxin Type A
Electric stimulationExperimentalTo inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation
Receives: Drug: Botulinum Toxin Type A
Surface anatomy landmarkActive comparatorTo inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Surface anatomy landmark.
Receives: Drug: Botulinum Toxin Type A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Ashworth Scale

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

    Measured: Change from Baseline Muscle Tone at 6 months

Secondary outcomes (13)

  1. Brunnstrome Stage

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

    Measured: Change from Baseline Condition at 6 months

  2. Active Range of Motion

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

    Measured: Change from Baseline Data at 6 months

  3. 4 Point Categorical Pain Intensity Scale

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

    Measured: Change from Baseline Data at 6 months

  4. Hand-grasp strength Assessment

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

    Measured: Change from Baseline Data at 6 months

  5. Pinch Strength Assessment

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

    Measured: Change from Baseline Data at 6 months

  6. Barthel Index

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

    Measured: Change from Baseline Data at 6 months

  7. Stroke Impact Scale (SIS)

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

    Measured: Change from Baseline Data at 6 months

  8. Action Research Arm Test (ARAT)

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

    Measured: Change from Baseline Data at 6 months

  9. Wolf Motor Function Test

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

    Measured: Change from Baseline Data at 6 months

  10. Chedoke Arm and Hand Activity Inventory (CAHAI)

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

    Measured: Change from Baseline Data at 6 months

  11. Fugl-Meyer Assessment

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

    Measured: Change from Baseline Data at 6 months

  12. Motor Activity Log Scale

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

    Measured: Change from Baseline Data at 6 months

  13. Nine Hole Peg Test

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

    Measured: Change from Baseline Data at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2015 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02557737
Sponsor's protocol ID
CMRPG8B0222
Status last verified
Mar 2016
First submitted
17 Sep 2015
Last updated
30 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mizrahi EM, Angel RW. Impairment of voluntary movement by spasticity. Ann Neurol. 1979 Jun;5(6):594-5. doi: 10.1002/ana.410050620. No abstract available.

    PubMed 475355

  • Gracies JM, Nance P, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part II: General and regional treatments. Muscle Nerve Suppl. 1997;6:S92-120.

    PubMed 9826984

  • Gracies JM, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part I: Local treatments. Muscle Nerve Suppl. 1997;6:S61-91.

    PubMed 9826983

  • Difazio M, Jabbari B. A focused review of the use of botulinum toxins for low back pain. Clin J Pain. 2002 Nov-Dec;18(6 Suppl):S155-62. doi: 10.1097/00002508-200211001-00007.

    PubMed 12569963

  • Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004 Jul;75(7):951-7. doi: 10.1136/jnnp.2003.034702.

    PubMed 15201348

  • Lim EC, Seet RC. Use of botulinum toxin in the neurology clinic. Nat Rev Neurol. 2010 Nov;6(11):624-36. doi: 10.1038/nrneurol.2010.149. Epub 2010 Oct 12.

    PubMed 21045798

  • Brashear A, Gordon MF, Elovic E, Kassicieh VD, Marciniak C, Do M, Lee CH, Jenkins S, Turkel C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400. doi: 10.1056/NEJMoa011892.

    PubMed 12167681

  • Yablon SA, Brashear A, Gordon MF, Elovic EP, Turkel CC, Daggett S, Liu J, Brin MF. Formation of neutralizing antibodies in patients receiving botulinum toxin type A for treatment of poststroke spasticity: a pooled-data analysis of three clinical trials. Clin Ther. 2007 Apr;29(4):683-90. doi: 10.1016/j.clinthera.2007.04.015.

    PubMed 17617291

  • Yablon SA, Agana BT, Ivanhoe CB, Boake C. Botulinum toxin in severe upper extremity spasticity among patients with traumatic brain injury: an open-labeled trial. Neurology. 1996 Oct;47(4):939-44. doi: 10.1212/wnl.47.4.939.

    PubMed 8857723

  • Bakheit AM, Thilmann AF, Ward AB, Poewe W, Wissel J, Muller J, Benecke R, Collin C, Muller F, Ward CD, Neumann C. A randomized, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke. 2000 Oct;31(10):2402-6. doi: 10.1161/01.str.31.10.2402.

    PubMed 11022071

  • Francisco GE. Botulinum toxin for post-stroke spastic hypertonia: a review of its efficacy and application in clinical practice. Ann Acad Med Singap. 2007 Jan;36(1):22-30.

    PubMed 17285183

  • 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.

    PubMed 15832139

  • 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.

    PubMed 11889247

  • 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.

    PubMed 16198612

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

    PubMed 9826989

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum Toxin Type A in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pong Ya-Ping, MD (889-7-7317123 ext. 6286, yaping0707@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Ashworth Scale (time frame: Change from Baseline Muscle Tone at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02557737, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016; AzTrials last refreshed its copy on 2 Nov 2026.

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