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Completed

NCT Number: NCT03549975

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic Hemiparesis Spasticity as Sequela of Stroke Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A 100 unit/Vial (Product)

Drug

Botulinum toxin type A injection followed by functional electrical stimulation

Other names: functional electrical stimulation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Rehabilitation Center, Seoul, Korea

Other Gov

Registry information

Official study title

Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation Among Stroke Patients With Limitation of Finger Extension Due to Spasticity- Pilot Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2018
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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