Schizophrenia and Schizoaffective DisorderNCT07086040
Effects of RAS in SZ
A study testing RAS incorporated in upper-limb movement training and Upper-limb movement training in people with Schizophrenia and Schizoaffective Disorder, run by Shu-Mei Wang at 1 site in Taiwan.
Trial summary
The two main groups of medicated patients with schizophrenia (SZ) are those receiving second-generation antipsychotics and those receiving first-generation antipsychotics. The purpose of this research project is to target each patient group to examine effects of rhythmic auditory stimulation (RAS) on upper-limb… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Schizoaffective Disorder
- What is being tested?
- RAS 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
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 31 Jul 2028
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A diagnosis of schizophrenia or schizoaffective disorder
- Between 18 to 60 years old
- Keeping the same antipsychotics and the same dosage at least 4 weeks right before joining the study
- A Edinburgh Handedness Inventory score of > 60
- A Montreal Cognitive Assessment score of ≥ 24
- Between 18 to 60 years old
- A Edinburgh Handedness Inventory score of > 60
- A Montreal Cognitive Assessment score of ≥ 24
Who cannot join
- Substance abuse or drug abuse
- Neurological diseases or medical conditions that affect upper-limb movements and hearing
- Other psychiatric diagnoses in addition to a diagnosis of schizophrenia or schizoaffective disorder
- [For healthy participants]
- Substance abuse or drug abuse
- Neurological diseases or medical conditions that affect upper-limb movements and hearing
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- Psychiatric diagnoses
- Taking psychotropic medications
- Presence of first-degree relatives or siblings with diagnoses of psychiatric diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Rhythmic Auditory Stimulation Therapy on Upper-Limb Movements, Function, and Quality of Life in Patients With Schizophrenia: Randomized Controlled Trials
The two main groups of medicated patients with schizophrenia (SZ) are those receiving second-generation antipsychotics and those receiving first-generation antipsychotics. The purpose of this research project is to target each patient group to examine effects of rhythmic auditory stimulation (RAS) on upper-limb movements in medicated SZ patients in a 6-month follow-up period.
The main questions of this project are:
Read more
- Does RAS reduce severity of upper-limb bradykinesia (slow movements) and dyskinesia (repetitive and involuntary movements) after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving second-generation antipsychotics? and
- Does RAS reduce severity of upper-limb bradykinesia and dyskinesia after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving first-generation antipsychotics?
Researchers will compare upper-limb movement training with the aid of RAS to upper-limb movement training without the aid of RAS to see if RAS works to improve upper-limb movements in SZ patients. Participants will:
- Undergo an interview and movement tests and fill out questionnaires before and after the movement training program and at 3-month follow-up and 6-month follow-up; and
- Receive movement training for 40 minutes per session for a total of 21 sessions.
- Being tested
- RAS incorporated in upper-limb movement training, Upper-limb movement training
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAS incorporated in upper-limb movement trainingBehavioural
RAS 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 for a total of 21 sessions.
Upper-limb movement trainingBehavioural
Upper-limb movement training will last for 40 minutes per session for a total of 21 sessions.
| Study group | Role | What they receive |
|---|---|---|
| SZ patients receiving second-generation antipsychotics + RAS | Experimental | SZ patients receiving second-generation antipsychotics: Provision of upper-limb movement training with the aid of RAS Receives: Behavioral: RAS incorporated in upper-limb movement training |
| SZ patients receiving second-generation antipsychotics + no RAS | Active comparator | SZ patients receiving second-generation antipsychotics: Provision of upper-limb movement training without the aid of RAS Receives: Behavioral: Upper-limb movement training |
| SZ patients receiving first-generation antipsychotics + RAS | Experimental | SZ patients receiving first-generation antipsychotics: Provision of upper-limb movement training with the aid of RAS Receives: Behavioral: RAS incorporated in upper-limb movement training |
| SZ patients receiving first-generation antipsychotics + no RAS | Active comparator | SZ patients receiving first-generation antipsychotics: Provision of upper-limb movement training without the aid of RAS Receives: Behavioral: Upper-limb movement training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purdue pegboard test
A larger value (the number of inserted pins) means a faster movement.
Measured: Up to 1 week right before the 1st session of the intervention
Purdue pegboard test
A larger value (the number of inserted pins) means a faster
Measured: Up to 1 week right after the last session of the intervention
Purdue pegboard test
A larger value (the number of inserted pins) means a faster movement.
Measured: After three months following the last session of the intervention
Purdue pegboard test
A larger value (the number of inserted pins) means a faster movement.
Measured: After six months following 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
Box and Block Test
A larger value (the number of blocks) means a faster movement.
Measured: After three months following the last session of the intervention
Box and Block Test
A larger value (the number of blocks) means a faster movement.
Measured: After six months following the last session of the intervention
Extrapyramidal Symptom Rating Scale
A larger score means more severe bradykinesia
Measured: Up to 1 week right before the 1st session of the intervention
Extrapyramidal Symptom Rating Scale
A larger score means more severe bradykinesia
Measured: Up to 1 week right after the last session of the intervention
Extrapyramidal Symptom Rating Scale
A larger score means more severe bradykinesia
Measured: After three months following the last session of the intervention
Extrapyramidal Symptom Rating Scale
A larger score means more severe bradykinesia
Measured: After six months following the last session of the intervention
Abnormal Involuntary Movement Scale
A larger score means more severe dyskinesia
Measured: Up to 1 week right before the 1st session of the intervention
Abnormal Involuntary Movement Scale
A larger score means more severe dyskinesia
Measured: Up to 1 week right after the last session of the intervention
Abnormal Involuntary Movement Scale
A larger score means more severe dyskinesia
Measured: After three months following the last session of the intervention
Abnormal Involuntary Movement Scale
A larger score means more severe dyskinesia
Measured: After six months following the last session of the intervention
Secondary outcomes (20)
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
Jebsen-Taylor Hand Function Test
A larger value (the time for completing the task) of each task means a slower movement.
Measured: After three months following the last 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: After six months following the last session of the intervention
Averaged weekly working hours
A larger value (working hours) means higher working function.
Measured: Up to 1 week right before the 1st session of the intervention
Averaged weekly working hours
A larger value (working hours) means higher working function.
Measured: Up to 1 week right after the last session of the intervention
Averaged weekly working hours
A larger value (working hours) means higher working function.
Measured: After three months following the last session of the intervention
Averaged weekly working hours
A larger value (working hours) means higher working function.
Measured: After six months following the last session of the intervention
The short version of the World Health Organization Quality of Life questionnaire
A larger score means higher quality of life.
Measured: Up to 1 week right before the 1st session of the intervention
The short version of the World Health Organization Quality of Life questionnaire
A larger score means higher quality of life.
Measured: Up to 1 week right after the last session of the intervention
The short version of the World Health Organization Quality of Life questionnaire
A larger score means higher quality of life.
Measured: After three months following the last session of the intervention
The short version of the World Health Organization Quality of Life questionnaire
A larger score means higher quality of life.
Measured: After six months following the last session of the intervention
Positive and Negative Syndrome Scale
A larger score means more severe psychotic symptoms.
Measured: Up to 1 week right before the 1st session of the intervention
Positive and Negative Syndrome Scale
A larger score means more severe psychotic symptoms.
Measured: Up to 1 week right after the last session of the intervention
Positive and Negative Syndrome Scale
A larger score means more severe psychotic symptoms.
Measured: After three months following the last session of the intervention
Positive and Negative Syndrome Scale
A larger score means more severe psychotic symptoms.
Measured: After six months following the last session of the intervention
The Montreal Cognitive Assessment
A larger score means higher cognition.
Measured: Up to 1 week right before the 1st session of the intervention
The Montreal Cognitive Assessment
A larger score means higher cognition.
Measured: Up to 1 week right after the last session of the intervention
The Montreal Cognitive Assessment
A larger score means higher cognition.
Measured: After three months following the last session of the intervention
The Montreal Cognitive Assessment
A larger score means higher cognition.
Measured: After six months following 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 posted25 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Schizoaffective DisorderStudies 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
- 140 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
- NCT07086040
- Sponsor's protocol ID
- RAS in SZ
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 25 Jul 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythmic Auditory Stimulation Therapy on Upper-Limb Movements, Function, and Quality of Life in Patients With Schizophrenia: Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT07086040
- Acronym / sponsor ID
- RAS in SZ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shu-Mei WangUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 25 Jul 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 two main groups of medicated patients with schizophrenia (SZ) are those receiving second-generation antipsychotics and those receiving first-generation antipsychotics. The purpose of this research project is to target each patient group to examine effects of rhythmic auditory stimulation (RAS) on upper-limb movements in medicated SZ patients in a 6-month follow-up period.
The main questions of this project are:
- Does RAS reduce severity of upper-limb bradykinesia (slow movements) and dyskinesia (repetitive and involuntary movements) after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving second-generation antipsychotics? and
- Does RAS reduce severity of upper-limb bradykinesia and dyskinesia after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving first-generation antipsychotics?
Researchers will compare upper-limb movement training with the aid of RAS to upper-limb movement training without the aid of RAS to see if RAS works to improve upper-limb movements in SZ patients. Participants will:
- Undergo an interview and movement tests and fill out questionnaires before and after the movement training program and at 3-month follow-up and 6-month follow-up; and
- Receive movement training for 40 minutes per session for a total of 21 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SZ patients receiving second-generation antipsychotics + RAS | Experimental | Behavioral: RAS incorporated in upper-limb movement trainingSZ patients receiving second-generation antipsychotics: Provision of upper-limb movement training with the aid of RAS |
| SZ patients receiving second-generation antipsychotics + no RAS | Active comparator | Behavioral: Upper-limb movement trainingSZ patients receiving second-generation antipsychotics: Provision of upper-limb movement training without the aid of RAS |
| SZ patients receiving first-generation antipsychotics + RAS | Experimental | Behavioral: RAS incorporated in upper-limb movement trainingSZ patients receiving first-generation antipsychotics: Provision of upper-limb movement training with the aid of RAS |
| SZ patients receiving first-generation antipsychotics + no RAS | Active comparator | Behavioral: Upper-limb movement trainingSZ patients receiving first-generation antipsychotics: Provision of upper-limb movement training without the aid of RAS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- A diagnosis of schizophrenia or schizoaffective disorder
- Between 18 to 60 years old
- Keeping the same antipsychotics and the same dosage at least 4 weeks right before joining the study
- A Edinburgh Handedness Inventory score of > 60
- A Montreal Cognitive Assessment score of ≥ 24
Key exclusion criteria (9 listed)
- Substance abuse or drug abuse
- Neurological diseases or medical conditions that affect upper-limb movements and hearing
- Other psychiatric diagnoses in addition to a diagnosis of schizophrenia or schizoaffective disorder
- [For healthy participants]
- Substance abuse or drug abuse
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 |
|---|---|---|
| RAS incorporated in upper-limb movement trainingRAS 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 for a total of 21 sessions. | Behavioural | SZ patients receiving first-generation antipsychotics + RAS, SZ patients receiving second-generation antipsychotics + RAS |
| Upper-limb movement trainingUpper-limb movement training will last for 40 minutes per session for a total of 21 sessions. | Behavioural | SZ patients receiving first-generation antipsychotics + no RAS, SZ patients receiving second-generation antipsychotics + no RAS |
Primary outcome
Purdue pegboard test
Time frame: Up to 1 week right before the 1st session of the intervention
A larger value (the number of inserted pins) means a faster movement.
Purdue pegboard test
Time frame: Up to 1 week right after the last session of the intervention
A larger value (the number of inserted pins) means a faster
Purdue pegboard test
Time frame: After three months following the last session of the intervention
A larger value (the number of inserted pins) means a faster movement.
Purdue pegboard test
Time frame: After six months following the last session of the intervention
A larger value (the number of inserted pins) means a faster 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.
Box and Block Test
Time frame: After three months following the last session of the intervention
A larger value (the number of blocks) means a faster movement.
Box and Block Test
Time frame: After six months following the last session of the intervention
A larger value (the number of blocks) means a faster movement.
Extrapyramidal Symptom Rating Scale
Time frame: Up to 1 week right before the 1st session of the intervention
A larger score means more severe bradykinesia
Extrapyramidal Symptom Rating Scale
Time frame: Up to 1 week right after the last session of the intervention
A larger score means more severe bradykinesia
Extrapyramidal Symptom Rating Scale
Time frame: After three months following the last session of the intervention
A larger score means more severe bradykinesia
Extrapyramidal Symptom Rating Scale
Time frame: After six months following the last session of the intervention
A larger score means more severe bradykinesia
Abnormal Involuntary Movement Scale
Time frame: Up to 1 week right before the 1st session of the intervention
A larger score means more severe dyskinesia
Abnormal Involuntary Movement Scale
Time frame: Up to 1 week right after the last session of the intervention
A larger score means more severe dyskinesia
Abnormal Involuntary Movement Scale
Time frame: After three months following the last session of the intervention
A larger score means more severe dyskinesia
Abnormal Involuntary Movement Scale
Time frame: After six months following the last session of the intervention
A larger score means more severe dyskinesia
20 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
Jebsen-Taylor Hand Function Test
Time frame: After three months following the last session of the intervention
Jebsen-Taylor Hand Function Test
Time frame: After six months following the last session of the intervention
Averaged weekly working hours
Time frame: Up to 1 week right before the 1st session of the intervention
Averaged weekly working hours
Time frame: Up to 1 week right after the last session of the intervention
Averaged weekly working hours
Time frame: After three months following the last session of the intervention
Averaged weekly working hours
Time frame: After six months following the last session of the intervention
The short version of the World Health Organization Quality of Life questionnaire
Time frame: Up to 1 week right before the 1st session of the intervention
The short version of the World Health Organization Quality of Life questionnaire
Time frame: Up to 1 week right after the last session of the intervention
The short version of the World Health Organization Quality of Life questionnaire
Time frame: After three months following the last session of the intervention
The short version of the World Health Organization Quality of Life questionnaire
Time frame: After six months following the last session of the intervention
Positive and Negative Syndrome Scale
Time frame: Up to 1 week right before the 1st session of the intervention
Positive and Negative Syndrome Scale
Time frame: Up to 1 week right after the last session of the intervention
Positive and Negative Syndrome Scale
Time frame: After three months following the last session of the intervention
Positive and Negative Syndrome Scale
Time frame: After six months following the last session of the intervention
The Montreal Cognitive Assessment
Time frame: Up to 1 week right before the 1st session of the intervention
The Montreal Cognitive Assessment
Time frame: Up to 1 week right after the last session of the intervention
The Montreal Cognitive Assessment
Time frame: After three months following the last session of the intervention
The Montreal Cognitive Assessment
Time frame: After six months following 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 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAS incorporated in upper-limb movement training and Upper-limb movement training in people with Schizophrenia and Schizoaffective Disorder, 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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 25 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Purdue pegboard test (time frame: Up to 1 week right before the 1st session of the intervention). The study lists 16 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 Jul 2025.