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

May 25, 2018 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • functional electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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.
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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).
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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.
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Grip strength
Time Frame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measured by Jamar dynamometer
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
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.
baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Rehabilitation Center, Seoul, Korea

Investigators

  • Principal Investigator: Joon-Ho Shin, MS, National Rehabilitation Center of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2016

Primary Completion (Actual)

August 18, 2017

Study Completion (Actual)

August 18, 2017

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC-2016-02-011

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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