NCT04929795

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 11, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

June 10, 2021

Last Update Submit

November 19, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)

    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)

    normalized movement time (representing severity of bradykinesia). Unit: second/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)

    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)

    normalized number of movement units (representing severity of dyskinesia). Unit: units/mm

    Within one week right after the last session of the intervention

Study Arms (4)

at risk- RAS

EXPERIMENTAL

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).

Behavioral: Rhythmic auditory stimulation (RAS)

at risk- no RAS

ACTIVE COMPARATOR

At-risk individuals in the control group will receive upper-limb training without the aid of RAS.

Behavioral: no RAS

schizophrenia- RAS

EXPERIMENTAL

Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of RAS.

Behavioral: Rhythmic auditory stimulation (RAS)

schizophrenia- no RAS

ACTIVE COMPARATOR

Schizophrenia patients in the control group will receive upper-limb training without the aid of RAS.

Behavioral: no RAS

Interventions

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.

at risk- RASschizophrenia- RAS
no RASBEHAVIORAL

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.

at risk- no RASschizophrenia- no RAS

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.
  • cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements;
  • substance abuse; and
  • being pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ST814, the Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

Related Publications (1)

  • Wang SM, Chan HY, Chan CY, Fong LY, Chan WL, Wu KY, Yip LC, Wong WY, Ng CL, Fong KNK. Effects of Music Rhythm on Movement Abnormalities in People With Psychotic-Like Experiences: A Pilot Randomised Controlled Trial Using Motion Analysis. Early Interv Psychiatry. 2025 Nov;19(11):e70111. doi: 10.1111/eip.70111.

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersParkinsonian DisordersDyskinesias

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Assistant Professor

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 18, 2021

Study Start

August 11, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations