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

Sponsor
Dr WANG Shumei (Other)
Overall Status
Recruiting
CT.gov ID
NCT04553835
Collaborator
(none)
60
1
4
28
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Rhythmic auditory stimulation (RAS) for schizophrenia patients
  • Behavioral: No RAS for schizophrenia patients
  • Behavioral: RAS for at-risk individuals
  • Behavioral: No RAS for at-risk individuals
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
Actual Study Start Date :
Aug 31, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: schizophrenia- RAS

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

Behavioral: 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.

Active Comparator: schizophrenia- no RAS

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

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.

Experimental: at risk- RAS

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

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.

Active Comparator: at risk- no RAS

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

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.

Outcome Measures

Primary Outcome Measures

  1. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right before the 1st session of the intervention]

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

  2. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right after the last session of the intervention]

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

  3. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right before the 1st session of the intervention]

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

  4. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right after the last session of the intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
For at-risk individuals:
The inclusion criteria for at-risk individuals are:
  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.

The inclusion criteria for healthy controls are:
  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:
The inclusion criteria for schizophrenia patients are:
  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.

The inclusion criteria for healthy controls are:
  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hong Kong Polytechnic University Kowloon Hong Kong

Sponsors and Collaborators

  • Dr WANG Shumei

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr WANG Shumei, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT04553835
Other Study ID Numbers:
  • HSEARS20200630002
First Posted:
Sep 17, 2020
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2022