Effects of RAS in SZ
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShu-Mei Wang
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Between 18 to 60 years old
Trial design
Design model
Parallel
Treatments tested in this trial
RAS incorporated in upper-limb movement training
BehavioralRAS 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
BehavioralUpper-limb movement training will last for 40 minutes per session for a total of 21 sessions.
Treatment groups
140 Participants
are divided into 4 treatment groupsGroup A: SZ patients receiving second-generation antipsychotics + RASExperimental treatment 1 intervention
Group B: SZ patients receiving second-generation antipsychotics + no RASActive comparator 1 intervention
Group C: SZ patients receiving first-generation antipsychotics + RASExperimental treatment 1 intervention
Group D: SZ patients receiving first-generation antipsychotics + no RASActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Purdue pegboard test
A larger value (the number of inserted pins) means a faster movement.
Time frame
Up to 1 week right before the 1st session of the intervention2
Purdue pegboard test
A larger value (the number of inserted pins) means a faster
Time frame
Up to 1 week right after the last session of the intervention3
Purdue pegboard test
A larger value (the number of inserted pins) means a faster movement.
Time frame
After three months following the last session of the intervention4
Purdue pegboard test
A larger value (the number of inserted pins) means a faster movement.
Time frame
After six months following the last session of the interventionSecondary outcomes
1
Jebsen-Taylor Hand Function Test
A larger value (the time for completing the task) of each task means a slower movement.
Time frame
Up to 1 week right before the 1st session of the intervention2
Jebsen-Taylor Hand Function Test
A larger value (the time for completing the task) of each task means a slower movement.
Time frame
Up to 1 week right after the last session of the intervention3
Jebsen-Taylor Hand Function Test
A larger value (the time for completing the task) of each task means a slower movement.
Time frame
After three months following the last session of the intervention4
Jebsen-Taylor Hand Function Test
A larger value (the time for completing the task) of each task means a slower movement.
Time frame
After six months following the last session of the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shu-Mei Wang
Lead sponsor
National Taipei University of Nursing and Health Sciences
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: