- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04929795
Effects of Music Beat on Motor Function in Individuals At Risk for Psychotic Onset and Schizophrenia Patients
November 19, 2024 updated by: Dr WANG Shumei
The purpose of this project is to investigate whether a 3-week training program involving music beat (serving as a type of rhythmic auditory stimulation) reduces the severity of bradykinesia and dyskinesia in at-risk individuals and schizophrenia patients.
It is hypothesized that the program is effective in reducing the severity of bradykinesia and dyskinesia in at-risk individuals and schizophrenia patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kowloon, Hong Kong
- ST814, the Hong Kong Polytechnic University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
For at-risk participants:
Inclusion criteria:
- A score of or above 9 in the Chinese version of the 16-item Prodromal Questionnaire (CPQ-16), or a score of or above 8.18 in the Chinese version of Community Assessment of Psychic Experiences with 15 items (CAPE-C15), or a score of or above 17 in Schizotypal Personality Questionnaire-Brief (SPQ-B);
- an age of 13 years or above;
- score > 60 in The Chinese version of Edinburgh Handedness Inventory (CH-EBI) to ensure right handedness; and
- score ≥ 22 in Montreal Cognitive Assessment Hong Kong Version (HK-MoCA) to ensure no serious cognitive deficits so that they can understand instructions.
Exclusion criteria:
- psychiatric diagnosis by self-report;
- cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements;
- taking psychiatric medications;
- substance abuse; and
- being pregnant.
For schizophrenia participants:
Inclusion criteria:
- a diagnosis of schizophrenia without other psychiatric diseases;
- the age ≥ 18 years;
- score > 60 in CH-EBI to ensure right handedness; and
- score ≥ 22 in HK-MoCA to ensure no serious cognitive deficits so that they can understand instructions.
Exclusion criteria:
- cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements;
- substance abuse; and
- being pregnant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: at risk- RAS
At-risk individuals in the experimental group will undergo upper-limb movement training with the aid of music beat serving as a type of rhythmic auditory stimulation (RAS).
|
The song named 'Sign of The Times' is played and recorded by the research personnel beforehand.
The beat of the song will serve as RAS.
The computer software "Audacity" will be used to adjust tempi of RAS.
Before intervention, the participant is required to execute the movement task without the aid of RAS as quickly as possible for 30 seconds, so that we obtain his/her baseline movement tempo.
For each 40-minute training session in the first training week, three RAS tempi will be provided for the first, second, and last 10 minutes with a five-minute break in between: normal (100% of the baseline tempo), quick (105% of the baseline tempo), and fast (110% of the baseline tempo).
With each training week, the three RAS tempi will be increased by 5%.
Participants in the experimental groups are required to use their right hand to pick up beads from source bowls to the target bowl when listening to the song.
The 3-week intervention program will include 21 40-minute daily training sessions.
|
|
Active Comparator: at risk- no RAS
At-risk individuals in the control group will receive upper-limb training without the aid of RAS.
|
The training protocol will be the same as that used in the experimental group except the lack of RAS during execution of the movement task.
|
|
Experimental: schizophrenia- RAS
Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of RAS.
|
The song named 'Sign of The Times' is played and recorded by the research personnel beforehand.
The beat of the song will serve as RAS.
The computer software "Audacity" will be used to adjust tempi of RAS.
Before intervention, the participant is required to execute the movement task without the aid of RAS as quickly as possible for 30 seconds, so that we obtain his/her baseline movement tempo.
For each 40-minute training session in the first training week, three RAS tempi will be provided for the first, second, and last 10 minutes with a five-minute break in between: normal (100% of the baseline tempo), quick (105% of the baseline tempo), and fast (110% of the baseline tempo).
With each training week, the three RAS tempi will be increased by 5%.
Participants in the experimental groups are required to use their right hand to pick up beads from source bowls to the target bowl when listening to the song.
The 3-week intervention program will include 21 40-minute daily training sessions.
|
|
Active Comparator: schizophrenia- no RAS
Schizophrenia patients in the control group will receive upper-limb training without the aid of RAS.
|
The training protocol will be the same as that used in the experimental group except the lack of RAS during execution of the movement task.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Time Frame: Within one week right before the 1st session of the intervention
|
normalized number of movement units (representing severity of dyskinesia).
Unit: units/mm
|
Within one week right before the 1st session of the intervention
|
|
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Time Frame: Within one week right after the last session of the intervention
|
normalized number of movement units (representing severity of dyskinesia).
Unit: units/mm
|
Within one week right after the last session of the intervention
|
|
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Time Frame: Within one week right before the 1st session of the intervention
|
normalized movement time (representing severity of bradykinesia).
Unit: second/mm
|
Within one week right before the 1st session of the intervention
|
|
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Time Frame: Within one week right after the last session of the intervention
|
normalized movement time (representing severity of bradykinesia).
Unit: second/mm
|
Within one week right after the last session of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 11, 2021
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
June 10, 2021
First Submitted That Met QC Criteria
June 10, 2021
First Posted (Actual)
June 18, 2021
Study Record Updates
Last Update Posted (Estimated)
November 21, 2024
Last Update Submitted That Met QC Criteria
November 19, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20210610001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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