StrokeNCT06830785
Effects of RAS in Stroke
A study testing rhythmic auditory stimulation incorporated in upper-limb movement training and Upper-limb movement training in people with Stroke, run by Shu-Mei Wang at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- rhythmic auditory stimulation incorporated in upper-limb movement training and Upper-limb movement training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taipei University of Nursing and Health Sciences
Taipei
Shu-Mei Wang, +886-2-28227101 ext.1289, shumei@ntunhs.edu.tw
About this study
Official title: 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?
Read more
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
- Conditions
- Stroke
- Being tested
- rhythmic auditory stimulation incorporated in upper-limb movement training, Upper-limb movement training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhythmic auditory stimulation incorporated in upper-limb movement trainingBehavioural
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.
Upper-limb movement trainingBehavioural
Upper-limb movement training will last for 40 minutes per session, three sessions per week, and a total of 24 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | provision of rhythmic auditory stimulation Receives: Behavioral: rhythmic auditory stimulation incorporated in upper-limb movement training |
| Control Group | Active comparator | no provision of rhythmic auditory stimulation Receives: Behavioral: Upper-limb movement training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine-Hole Peg Test
A larger value (the recorded time for completing the task) means a slower movement.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 week right after the last session of the intervention
Secondary outcomes (6)
Jebsen-Taylor Hand Function Test
A larger value (the time for completing the task) of each task means a slower movement.
Measured: 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.
Measured: Up to 1 week right after the last session of the intervention
the Fugl-Meyer Assessment
A higher value means better movement recovery.
Measured: Up to 1 week right before the 1st session of the intervention
the Fugl-Meyer Assessment
A higher value means better movement recovery.
Measured: Up to 1 week right after the last session of the intervention
the Stroke Impact Scale
A larger value means better quality of life.
Measured: Up to 1 week right before the 1st session of the intervention
the Stroke Impact Scale
A larger value means better quality of life.
Measured: Up to 1 week right after the last session of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start26 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shu-Mei Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shu-Mei Wang, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830785
- Sponsor's protocol ID
- RAS in stroke patients
- Status last verified
- Jun 2025
- First submitted
- 11 Feb 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythmic Auditory Stimulation on Upper-limb Movements, Function, and Quality of Life in Stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06830785
- Acronym / sponsor ID
- RAS in stroke patients
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Shu-Mei WangUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Behavioral: rhythmic auditory stimulation incorporated in upper-limb movement trainingprovision of rhythmic auditory stimulation |
| Control Group | Active comparator | Behavioral: Upper-limb movement trainingno provision of rhythmic auditory stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (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;
Key exclusion criteria (2 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhythmic auditory stimulation incorporated in upper-limb movement trainingRhythmic 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. | Behavioural | Experiment group |
| Upper-limb movement trainingUpper-limb movement training will last for 40 minutes per session, three sessions per week, and a total of 24 sessions. | Behavioural | Control Group |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
Jebsen-Taylor Hand Function Test
Time frame: 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
the Fugl-Meyer Assessment
Time frame: 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
the Stroke Impact Scale
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
National Taipei University of Nursing and Health Sciences
Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhythmic auditory stimulation incorporated in upper-limb movement training and Upper-limb movement training in people with Stroke, run by Shu-Mei Wang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine-Hole Peg Test (time frame: Up to 1 week right before the 1st session of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.