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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Rehabilitation Center, Seoul, Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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