Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke

April 12, 2024 updated by: National Cheng-Kung University Hospital

Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke: a Case Series Study

There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities. Minimal detectable change (MDC) and minimal important difference (MID) criteria were applied to interpret changes in assessment scores.

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.
3

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.
  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hemiparesis after stroke
  • At least 6 months post-stroke
  • Aged between 20 and 80 years
  • Upper extremity Brunnstrom stage IV or V
  • In stable medical condition
  • No cognitive deficits (able to understand and follow the instructions)

Exclusion Criteria:

  • Sensory impairment which may limit the participation in vibration stimulation treatment
  • Other neurological or musculoskeletal impairments
  • More than 2 by the Modified Ashworth Scale (0-5)
  • Skin problems that prohibit participants from wearing the vibratory gloves
  • Aphasia
  • Apraxia
  • Received other treatments which may influence motor or sensory abilities
  • Participating in other studies in the past 6 months

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: Vibration stimulation combined with task-oriented training
Device: Vibration stimulation combined with task-oriented training
Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy.

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
Fugl-Meyer assessment - wrist and hand
Time Frame: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Fugl-Meyer assessment - wrist and hand is used to assess wrist and hand motor impairments in people with post stroke hemiplegia. Scoring is conducted through the direct assessment of the individual's performance, whereby the 12 items on the scale are scored according to their level of completion using a 3-point ordinal scale: 0 indicating inability to perform, 1 indicating partial performance, and 2 indicating full performance. The minimum score is 0. The total score is 24. The higher the score, the better the hand and wrist motor function.
At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Box and Blocks Test
Time Frame: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Box and Blocks Test is a test of manual dexterity to assess hand function. The minimum score is 0. The total score is based on the number of blocks transferred from one box to the other in 60 seconds. Higher score is indicative of better hand dexterity.
At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Motor Activity Log
Time Frame: At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
The Motor Activity Log is a structured interview intended to measure an individual's real life functional affected upper limb performance. The Motor Activity Log consists of two subtests: one pertaining to the amount of use (AOU) and the other pertaining to the quality of movement (QOM) of the affected upper limb. The Motor Activity Log employs an 11-point Likert scale, ranging from 0 to 5 with half-point increments, to evaluate the AOU and QOM subtests. The scores for AOU vary from 0, indicating never use the affected limb for this activity, to 5, indicating always use. Similarly, the scores for QOM range from 0, representing an inability to use the affected limb during the activity, to 5, indicating an ability to use the affected limb just as proficiently as before the stroke. Higher scores represent better performance.
At baseline, 1 month after the start of the treatment, 2 months after the start of the treatment, 3 months after the start of the treatment, 1 month after the treatment ends and 3 months after the treatment ends.
Quantitative Electroencephalography Analysis: Delta Brain Symmetry Index
Time Frame: At baseline, 3 months after the start of the treatment and 3 months after the treatment ends.
The Delta Brain Symmetry Index is a quantitative electroencephalography analysis used to assess hemispheric power lateralization and reflect improvements in hand motor functions. Delta Brain Symmetry Index ranges from 0 to 1, with higher indices indicating greater asymmetry and lower indices indicating more symmetry. Decreased Delta Brain Symmetry indicates a decrease in lateralization, potentially associated with brain reorganization that supports motor recovery.
At baseline, 3 months after the start of the treatment and 3 months after the treatment ends.

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 Cheng-Kung University Hospital

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.
January 1, 2017

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.
June 15, 2019

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.
November 15, 2019

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).
March 29, 2024

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.
April 12, 2024

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.
April 16, 2024

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.
April 16, 2024

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.
April 12, 2024

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.
March 1, 2024

More Information

Terms related to this study

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.
  • B-ER-103-417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Quantitative Electroencephalography (QEEG): changes in hemispheric power lateralization. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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