Effects of RAS in SZ

NCT07086040 | Not Yet Recruiting

• 1 other identifier: RAS in SZ
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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 movements in medicated SZ patients in a 6-month follow-up period. The main questions of this project are:

1. 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. 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?
3. 3.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
4. 4.Receive movement training for 40 minutes per session for a total of 21 sessions.

Conditions

Schizophrenia and Schizoaffective Disorder

Outcome Measures

Primary Outcomes (16)

• Purdue pegboard test

  A larger value (the number of inserted pins) means a faster movement.

  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

  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.

  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.

  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.

  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

• Box and Block Test

  A larger value (the number of blocks) means a faster movement.

  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.

  After six months following the last session of the intervention

• Extrapyramidal Symptom Rating Scale

  A larger score means more severe bradykinesia

  Up to 1 week right before the 1st session of the intervention

• Extrapyramidal Symptom Rating Scale

  A larger score means more severe bradykinesia

  Up to 1 week right after the last session of the intervention

• Extrapyramidal Symptom Rating Scale

  A larger score means more severe bradykinesia

  After three months following the last session of the intervention

• Extrapyramidal Symptom Rating Scale

  A larger score means more severe bradykinesia

  After six months following the last session of the intervention

• Abnormal Involuntary Movement Scale

  A larger score means more severe dyskinesia

  Up to 1 week right before the 1st session of the intervention

• Abnormal Involuntary Movement Scale

  A larger score means more severe dyskinesia

  Up to 1 week right after the last session of the intervention

• Abnormal Involuntary Movement Scale

  A larger score means more severe dyskinesia

  After three months following the last session of the intervention

• Abnormal Involuntary Movement Scale

  A larger score means more severe dyskinesia

  After six months following the last session of the intervention

Secondary Outcomes (20)

• Jebsen-Taylor Hand Function Test

  Up to 1 week right before the 1st session of the intervention

• Jebsen-Taylor Hand Function Test

  Up to 1 week right after the last session of the intervention

• Jebsen-Taylor Hand Function Test

  After three months following the last session of the intervention

• Jebsen-Taylor Hand Function Test

  After six months following the last session of the intervention

• Averaged weekly working hours

  Up to 1 week right before the 1st session of the intervention

Study Arms (4)

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

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

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

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

Behavioral: Upper-limb movement training

Interventions

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.

SZ patients receiving first-generation antipsychotics + RAS; SZ patients receiving second-generation antipsychotics + RAS

Upper-limb movement training BEHAVIORAL

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

SZ patients receiving first-generation antipsychotics + no RAS; SZ patients receiving second-generation antipsychotics + no RAS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• \[For healthy participants\]
• Between 18 to 60 years old
• A Edinburgh Handedness Inventory score of \> 60
• A Montreal Cognitive Assessment score of ≥ 24
• 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.

Sponsors & Collaborators

• Shu-Mei Wang: lead

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)