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Effects of RAS in SZ

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07086040
Enrollment
140
Registered
2025-07-25
Start date
2025-08-01
Completion date
2028-07-31
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia and Schizoaffective Disorder

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. 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.

Interventions

BEHAVIORALRAS incorporated in upper-limb movement training

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 will last for 40 minutes per session for a total of 21 sessions.

Sponsors

Shu-Mei Wang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

\[For SZ patients\] 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

Design outcomes

Primary

MeasureTime frameDescription
Purdue pegboard testUp to 1 week right before the 1st session of the interventionA larger value (the number of inserted pins) means a faster movement.
Box and Block TestUp to 1 week right before the 1st session of the interventionA larger value (the number of blocks) means a faster movement.
Extrapyramidal Symptom Rating ScaleUp to 1 week right before the 1st session of the interventionA larger score means more severe bradykinesia
Abnormal Involuntary Movement ScaleUp to 1 week right before the 1st session of the interventionA larger score means more severe dyskinesia

Secondary

MeasureTime frameDescription
Jebsen-Taylor Hand Function TestUp to 1 week right before the 1st session of the interventionA larger value (the time for completing the task) of each task means a slower movement.
The Montreal Cognitive AssessmentUp to 1 week right before the 1st session of the interventionA larger score means higher cognition.
Averaged weekly working hoursUp to 1 week right before the 1st session of the interventionA larger value (working hours) means higher working function.
The short version of the World Health Organization Quality of Life questionnaireUp to 1 week right before the 1st session of the interventionA larger score means higher quality of life.
Positive and Negative Syndrome ScaleUp to 1 week right before the 1st session of the interventionA larger score means more severe psychotic symptoms.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026