Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07086040

Effects of RAS in SZ

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:

1. 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 2. 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:

1. 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 2. Receive movement training for 40 minutes per session for a total of 21 sessions.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Schizophrenia and Schizoaffective Disorder Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health Sciences

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

[For SZ patients]

Inclusion criteria

  • 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

Exclusion criteria

  • 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]

Inclusion criteria

  • Between 18 to 60 years old
  • A Edinburgh Handedness Inventory score of > 60
  • A Montreal Cognitive Assessment score of ≥ 24

Exclusion criteria

  • Substance abuse or drug abuse
  • Neurological diseases or medical conditions that affect upper-limb movements and hearing
  • Psychiatric diagnoses
  • Taking psychotropic medications
  • Presence of first-degree relatives or siblings with diagnoses of psychiatric diseases.

Treatment and study plan

RAS incorporated in upper-limb movement training

Behavioral

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 training

Behavioral

Upper-limb movement training will last for 40 minutes per session for a total of 21 sessions.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. Extrapyramidal Symptom Rating Scale

    Time frame: After three months following the last session of the intervention

    A larger score means more severe bradykinesia

  12. Extrapyramidal Symptom Rating Scale

    Time frame: After six months following the last session of the intervention

    A larger score means more severe bradykinesia

  13. 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

  14. 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

  15. Abnormal Involuntary Movement Scale

    Time frame: After three months following the last session of the intervention

    A larger score means more severe dyskinesia

  16. Abnormal Involuntary Movement Scale

    Time frame: After six months following the last session of the intervention

    A larger score means more severe dyskinesia

Secondary outcomes

  1. 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.

  2. 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.

  3. Jebsen-Taylor Hand Function Test

    Time frame: After three months following the last session of the intervention

    A larger value (the time for completing the task) of each task means a slower movement.

  4. Jebsen-Taylor Hand Function Test

    Time frame: After six months following the last session of the intervention

    A larger value (the time for completing the task) of each task means a slower movement.

  5. Averaged weekly working hours

    Time frame: Up to 1 week right before the 1st session of the intervention

    A larger value (working hours) means higher working function.

  6. Averaged weekly working hours

    Time frame: Up to 1 week right after the last session of the intervention

    A larger value (working hours) means higher working function.

  7. Averaged weekly working hours

    Time frame: After three months following the last session of the intervention

    A larger value (working hours) means higher working function.

  8. Averaged weekly working hours

    Time frame: After six months following the last session of the intervention

    A larger value (working hours) means higher working function.

  9. 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

    A larger score means higher quality of life.

  10. 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

    A larger score means higher quality of life.

  11. The short version of the World Health Organization Quality of Life questionnaire

    Time frame: After three months following the last session of the intervention

    A larger score means higher quality of life.

  12. The short version of the World Health Organization Quality of Life questionnaire

    Time frame: After six months following the last session of the intervention

    A larger score means higher quality of life.

  13. Positive and Negative Syndrome Scale

    Time frame: Up to 1 week right before the 1st session of the intervention

    A larger score means more severe psychotic symptoms.

  14. Positive and Negative Syndrome Scale

    Time frame: Up to 1 week right after the last session of the intervention

    A larger score means more severe psychotic symptoms.

  15. Positive and Negative Syndrome Scale

    Time frame: After three months following the last session of the intervention

    A larger score means more severe psychotic symptoms.

  16. Positive and Negative Syndrome Scale

    Time frame: After six months following the last session of the intervention

    A larger score means more severe psychotic symptoms.

  17. The Montreal Cognitive Assessment

    Time frame: Up to 1 week right before the 1st session of the intervention

    A larger score means higher cognition.

  18. The Montreal Cognitive Assessment

    Time frame: Up to 1 week right after the last session of the intervention

    A larger score means higher cognition.

  19. The Montreal Cognitive Assessment

    Time frame: After three months following the last session of the intervention

    A larger score means higher cognition.

  20. The Montreal Cognitive Assessment

    Time frame: After six months following the last session of the intervention

    A larger score means higher cognition.

Sponsors and collaborators

Lead sponsor

Shu-Mei Wang

Other

Registry information

Official study title

Effects of Rhythmic Auditory Stimulation Therapy on Upper-Limb Movements, Function, and Quality of Life in Patients With Schizophrenia: Randomized Controlled Trials

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.