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Effects of RAS in SZ

No phase Interventional Schizophrenia and Schizoaffective Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RAS incorporated in upper-limb movement training, Upper-limb movement training.
Who it may be relevant to
Registry conditions: Schizophrenia and Schizoaffective Disorder. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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

Primary outcome measures

  • Purdue pegboard test [Time frame: Up to 1 week right before the 1st session of the intervention]
  • Purdue pegboard test [Time frame: Up to 1 week right after the last session of the intervention]
  • Purdue pegboard test [Time frame: After three months following the last session of the intervention]
  • Purdue pegboard test [Time frame: After six months following the last session of the intervention]
  • Box and Block Test [Time frame: Up to 1 week right before the 1st session of the intervention]
  • Box and Block Test [Time frame: Up to 1 week right after the last session of the intervention]
  • Box and Block Test [Time frame: After three months following the last session of the intervention]
  • Box and Block Test [Time frame: After six months following the last session of the intervention]
  • Extrapyramidal Symptom Rating Scale [Time frame: Up to 1 week right before the 1st session of the intervention]
  • Extrapyramidal Symptom Rating Scale [Time frame: Up to 1 week right after the last session of the intervention]
Secondary outcome measures (12)
  • 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]

Eligibility 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taipei University of Nursing and Health Sciences — Taipei

Identifiers

NCT: NCT07086040 · RAS in SZ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗