Effects of RAS in Stroke

June 19, 2025 updated by: Shu-Mei Wang

Effects of Rhythmic Auditory Stimulation on Upper-limb Movements, Function, and Quality of Life in Stroke Patients: A Randomized Controlled Trial

The goal of this study is to to examine whether rhythmic auditory stimulation improved movement speed, movement function of executing activities of daily living, and movement recovery of the affected upper limb, as well as quality of life in stroke patients. The main questions it aims to answer are:

  • Does rhythmic auditory stimulation improve movement speed in stroke patients?
  • Does rhythmic auditory stimulation improve movement function of executing activities of daily living in stroke patients?
  • Does rhythmic auditory stimulation improve movement recovery of the affected upper limb in stroke patients?
  • Does rhythmic auditory stimulation improve quality of life in stroke patients?

Researchers will compare movement training with the aid of rhythmic auditory stimulation to movement training without the aid of rhythmic auditory stimulation to see if rhythmic auditory stimulation works to improve movement speed, movement function of executing activities of daily living, and movement recovery of the affected upper limb, as well as quality of life in stroke patients.

Participants will:

  • Undergo movement tests and fill out questionnaires before and after the movement training program
  • Receive movement training for 40 minutes per session and three sessions per week for a total of 24 sessions

Study Overview

Status

Status

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

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 (Estimated)

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.
68

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taipei University of Nursing and Health Sciences
        • Contact:

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:

  • (1) Diagnosed with either ischaemic or hemorrhagic stroke, and a first-time occurrence;
  • (2) A unilateral stroke;
  • (3) The onset occurred six months or more prior to the experiment, indicating a chronic stage of stroke;
  • (4) The affected upper limb's proximal and distal joints are between Brunnstrom stages four to six, ensuring that the affected limb can execute the upper-limb functional movement training of this study;
  • (5) The affected upper limb's Modified Ashworth Scale score is ≤ 2, indicating no significant muscle stiffness (spasticity) in the affected limb;
  • (6) A Montreal Cognitive Assessment score of ≥ 24, ensuring comprehension of the instructions given during this study;
  • and (7) when we clap hands next to the affected ear of the participant who closes eyes, the participant is able to indicate the sound's source either verbally or through gestures, indicating no complete hearing loss in the affected ear and the ability to receive rhythmic auditory stimulation.

Exclusion Criteria:

  • (1) Neurological diseases or medical conditions that affect upper-limb movements or hearing;
  • (2) Being participating in other experimental studies related to drug treatment or upper-limb movement therapy.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Experiment group
provision of rhythmic auditory stimulation
Behavioral: rhythmic auditory stimulation incorporated in upper-limb movement training
Rhythmic auditory stimulation will be metronome beat sound with different tempi and will be incorporated in upper-limb movement training, which will last for 40 minutes per session, three sessions per week, and a total of 24 sessions.
Active Comparator: Control Group
no provision of rhythmic auditory stimulation
Behavioral: Upper-limb movement training
Upper-limb movement training will last for 40 minutes per session, three sessions per week, and a total of 24 sessions.

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
Nine-Hole Peg Test
Time Frame: Up to 1 week right before the 1st session of the intervention
A larger value (the recorded time for completing the task) means a slower movement.
Up to 1 week right before the 1st session of the intervention
Nine-Hole Peg Test
Time Frame: Up to 1 week right after the last session of the intervention
A larger value (the recorded time for completing the task) means a slower movement.
Up to 1 week right after the last session of the intervention
Box and Block Test
Time Frame: Up to 1 week right before the 1st session of the intervention
A larger value (the number of blocks) means a faster movement.
Up to 1 week right before the 1st session of the intervention
Box and Block Test
Time Frame: Up to 1 week right after the last session of the intervention
A larger value (the number of blocks) means a faster movement.
Up to 1 week right after the last session of the intervention

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
Jebsen-Taylor Hand Function Test
Time Frame: Up to 1 week right before the 1st session of the intervention
A larger value (the time for completing the task) of each task means a slower movement.
Up to 1 week right before the 1st session of the intervention
Jebsen-Taylor Hand Function Test
Time Frame: Up to 1 week right after the last session of the intervention
A larger value (the time for completing the task) of each task means a slower movement.
Up to 1 week right after the last session of the intervention
the Fugl-Meyer Assessment
Time Frame: Up to 1 week right before the 1st session of the intervention
A higher value means better movement recovery.
Up to 1 week right before the 1st session of the intervention
the Fugl-Meyer Assessment
Time Frame: Up to 1 week right after the last session of the intervention
A higher value means better movement recovery.
Up to 1 week right after the last session of the intervention
the Stroke Impact Scale
Time Frame: Up to 1 week right before the 1st session of the intervention
A larger value means better quality of life.
Up to 1 week right before the 1st session of the intervention
the Stroke Impact Scale
Time Frame: Up to 1 week right after the last session of the intervention
A larger value means better quality of life.
Up to 1 week right after the last session of the intervention

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.
Shu-Mei Wang

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.
March 26, 2025

Primary Completion (Estimated)

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.
December 31, 2026

Study Completion (Estimated)

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.
December 31, 2026

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).
February 11, 2025

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.
February 11, 2025

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.
February 17, 2025

Study Record Updates

Last Update Posted (Estimated)

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 25, 2025

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.
June 19, 2025

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.
June 1, 2025

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.
  • RAS in stroke patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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