Effects of RAS in Stroke

NCT ID: NCT06830785

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experiment group

provision of rhythmic auditory stimulation

Group Type EXPERIMENTAL

rhythmic auditory stimulation incorporated in upper-limb movement training

Intervention Type BEHAVIORAL

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.

Control Group

no provision of rhythmic auditory stimulation

Group Type ACTIVE_COMPARATOR

Upper-limb movement training

Intervention Type BEHAVIORAL

Upper-limb movement training will last for 40 minutes per session, three sessions per week, and a total of 24 sessions.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shu-Mei Wang

OTHER

Sponsor Role lead

Responsible Party

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Shu-Mei Wang

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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National Taipei University of Nursing and Health Sciences

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Shu-Mei Wang

Role: primary

+886-2-28227101 ext.1289

Other Identifiers

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RAS in stroke patients

Identifier Type: -

Identifier Source: org_study_id

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