Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients

NCT ID: NCT04553835

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2022-12-31

Brief Summary

The purpose of this research is to examine effects of movement training with the aid of rhythmic auditory stimulation (RAS) on reducing severity of dyskinesia and bradykinesia in at-risk individuals and schizophrenia patients. The investigators hypothesize that training with the aid of RAS reduced severity of bradykinesia and dyskinesia in at-risk individuals as well as in schizophrenia patients.

Conditions

Schizophrenia; Psychosis; Parkinsonism; Dyskinesias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

schizophrenia- RAS

Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of rhythmic auditory stimulation (RAS).

Group Type: EXPERIMENTAL

Rhythmic auditory stimulation (RAS) for schizophrenia patients

Intervention Type: BEHAVIORAL

A mobile application, "metronome beats" developed by Stonekick Limited, will be used to give RAS when the participant executes the movement. 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 (beats per minute). 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%. Schizophrenia patients in the experimental group will undergo upper limb movement training with the aid of RAS. The intervention protocol will last for 3 weeks on the weekday basis (a total of 15 sessions) with one session (40 minutes) per weekday.

schizophrenia- no RAS

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

Group Type: ACTIVE_COMPARATOR

No RAS for schizophrenia patients

Intervention Type: BEHAVIORAL

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- RAS

At-risk individuals in the experimental group will undergo upper-limb movement training with the aid of RAS.

Group Type: EXPERIMENTAL

RAS for at-risk individuals

Intervention Type: BEHAVIORAL

A mobile application, "metronome beats" developed by Stonekick Limited, will be used to give RAS when the participant executes the movement. 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 (beats per minute). 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%. At-risk individuals in the experimental group will undergo upper limb movement training with the aid of RAS. The intervention protocol will last for 3 weeks on daily basis (a total of 21 sessions), with one training session (40 minutes) per day.

at risk- no RAS

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

Group Type: ACTIVE_COMPARATOR

No RAS for at-risk individuals

Intervention Type: BEHAVIORAL

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.

Interventions

Rhythmic auditory stimulation (RAS) for schizophrenia patients

A mobile application, "metronome beats" developed by Stonekick Limited, will be used to give RAS when the participant executes the movement. 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 (beats per minute). 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%. Schizophrenia patients in the experimental group will undergo upper limb movement training with the aid of RAS. The intervention protocol will last for 3 weeks on the weekday basis (a total of 15 sessions) with one session (40 minutes) per weekday.

Intervention Type: BEHAVIORAL

No RAS for schizophrenia patients

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.

Intervention Type: BEHAVIORAL

RAS for at-risk individuals

A mobile application, "metronome beats" developed by Stonekick Limited, will be used to give RAS when the participant executes the movement. 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 (beats per minute). 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%. At-risk individuals in the experimental group will undergo upper limb movement training with the aid of RAS. The intervention protocol will last for 3 weeks on daily basis (a total of 21 sessions), with one training session (40 minutes) per day.

Intervention Type: BEHAVIORAL

No RAS for at-risk individuals

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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);

2. A score of or above 22 in the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) to ensure that they can understand instructions;

3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory to ensure that they are right-handed.

4. The age ≥ 13 years.

1. A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;

2. A score of or above 22 in MoCA;

3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;

4. No first-degree family members having a diagnosis of mental illnesses.

5. The age ≥ 13 years.

At-risk participants and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.

For schizophrenia patients:

1. A diagnosis of schizophrenia without other psychiatric diseases;

2. Having stable psychotic symptoms;

3. A score of or above 22 in HK-MoCA;

4. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory.

5. The age ≥ 18 years.

1. A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;

2. A score of or above 22 in MoCA;

3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;

4. No first-degree family members having a diagnosis of mental illnesses.

5. The age ≥ 18 years.

Patients and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr WANG Shumei

OTHER

Sponsor Role: lead

Responsible Party

Dr WANG Shumei

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hong Kong Polytechnic University

Kowloon, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Shu-Mei Wang, PhD

Role: CONTACT

shumei.wang@polyu.edu.hk

852-27664197

Facility Contacts

Shu-Mei Wang, PhD

Role: primary

shumei.wang@polyu.edu.hk

852-27664197

Other Identifiers

HSEARS20200630002

Identifier Type: -

Identifier Source: org_study_id