Effects of RAS in Stroke

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: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: rhythmic auditory stimulation incorporated in upper-limb movement training; Behavioral: Upper-limb movement training

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taipei University of Nursing and Health Sciences
    • Contact: Shu-Mei Wang; Phone Number: +886-2-28227101 ext.1289; Email: shumei@ntunhs.edu.tw

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Nine-Hole Peg Test	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Jebsen-Taylor Hand Function Test	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	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	A higher value means better movement recovery.	Up to 1 week right before the 1st session of the intervention
the Fugl-Meyer Assessment	A higher value means better movement recovery.	Up to 1 week right after the last session of the intervention
the Stroke Impact Scale	A larger value means better quality of life.	Up to 1 week right before the 1st session of the intervention
the Stroke Impact Scale	A larger value means better quality of life.	Up to 1 week right after the last session of the intervention

Collaborators and Investigators

• Sponsor: Shu-Mei Wang

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID 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