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Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study

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ClinicalTrials.gov Identifier: NCT03549975
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Study Description
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Brief Summary:
The investigator tried to find out possibility of functional improvement using botulinum toxin injection targeting finger flexor spasticity with functional electrical stimulation among chronic stroke patients who did not show any improvement in hand function.

Condition or disease Intervention/treatment Phase
Stroke Spastic Hemiparesis Spasticity as Sequela of Stroke Drug: Botulinum Toxin Type A 100 unit/Vial (Product) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation Among Stroke Patients With Limitation of Finger Extension Due to Spasticity- Pilot Study
Actual Study Start Date : May 18, 2016
Actual Primary Completion Date : August 18, 2017
Actual Study Completion Date : August 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Botulinum toxin type A injection
Botulinum toxin type A injection followed by functional electrical stimulation
 Drug: Botulinum Toxin Type A 100 unit/Vial (Product)
Botulinum toxin type A injection followed by functional electrical stimulation
Other Name: functional electrical stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Change in Box and Block test [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    number of box moved by affected upper extremity

  2. Change of Action Research Arm Test [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    Score of Action Research Arm Test


Secondary Outcome Measures :
  1. Muscle strength of finger extensor [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    Medical research council grading of muscle strength

  2. Spasticity of finger extensor [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    Modified ashworth scale of finger flexor

  3. active range of motion of wrist joint [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    active range of motion of wrist joint

  4. Brunnstrom stage of stroke recovery of distal upper extremity [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    Brunnstrom stage of stroke recovery of distal upper extremity. By observing the pattern of participants posture, the stage was scored. The stage ranges from 1 to 6. Higher is better.

  5. Distance from middle finger tip to mid-palmar crease [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    Distance from middle finger tip to mid-palmar crease

  6. Repeated number of finger extension and flexion [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    Repeated number of finger extension and flexion

  7. Quick Disabilities of Arm, Shoulder & Hand [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]

    Quick Disabilities of Arm, Shoulder & Hand is questionnaire about patients' symptoms as well as ability to perform certain activities in the last week.

    Total score is obtained by summing the each question, and ranges from 0 (no disability) to 100 (most severe disability).


  8. Grading of active thumb opposition [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    Grading of active thumb opposition. It is measured by observing the pattern of thumb opposition.

  9. Grip strength [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    measured by Jamar dynamometer

  10. Active finger extension [ Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    Active finger extension. It is graded by observation of voluntary finger extension.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age over 18 years
  • hemiplegic upper limb spasticity secondary to a unilateral ischemic or hemorrhagic stroke
  • fingers and wrist flexor spasticity graded at least 1+ on the Modified Ashworth Scale
  • at least 6 months since stroke

Exclusion Criteria:

  • fixed contracture
  • previous treatment of the upper limb spasticity with neurolytic or surgical procedure
  • treatment with botulinum toxin type A in the previous 4 months
  • any active device implant
  • any neurological disorder, other than stroke causing motor deficits or spasticity
  • inability to attend to and/or to cooperate with all outcome measure-related task secondary to cognitive impairment or aphasia
  • pregnancy, planned pregnancy, or lactation
  • contraindication to botulinum toxin type A
Contacts and Locations
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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): NCT03549975


Sponsors and Collaborators
National Rehabilitation Center, Seoul, Korea
Investigators
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Principal Investigator: Joon-Ho Shin, MS National Rehabilitation Center of Korea
More Information
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Responsible Party: Joon-Ho Shin, Team manager of Department of Neurorehabilitation, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT03549975    
Other Study ID Numbers: NRC-2016-02-011
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea:
stroke
hand
botulinum toxin
functional electrical stimulation
Additional relevant MeSH terms:
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Muscle Spasticity
Stroke
Paresis
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
Botulinum Toxins
Botulinum Toxins, Type A
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