Effects and Mechanisms of RAS Training on Upper-limb Movements in PD Patients

March 13, 2023 updated by: FAN Wei, The Hong Kong Polytechnic University

Effects and Neural Mechanisms of Training Involving Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease

Introduction Bradykinesia (i.e., slow movements) is one of the most prominent symptoms of Parkinson's disease (PD) and has a negative impact on quality of life. Rhythmic auditory stimulation (RAS), a widely used and promising treatment technique, has been shown to effectively improve gait speed in PD patients. However, only few studies have explored effects and neural mechanisms of RAS on upper-limb movements. We will conduct two studies to investigate effects and mechanisms of RAS on upper-limb movements in PD patients. The purpose of this study is to examine effects and neural mechanisms of upper-limb movement training involving RAS in PD patients.

Methods This study will recruit patients with PD and healthy controls. This study will randomly assign PD patients into two groups: the PD-RAS group and the PD-noRAS group, and healthy controls into the HC-RAS group and the HC-noRAS group. A 7-day upper-limb training involving RAS (for the PD-RAS group and the HC-RAS group) or without RAS (for the PD-noRAS group and the HC-noRAS group) will be provided. EEG and behavioral assessments will be conducted before and after the first day of training, and after the seven-day training program. Two-way repeated measures analysis of variance will be performed to investigate the group and time effects on upper-limb function and neural activity.

Study significance The training program will serve as a reference for clinical practitioners who are interested in using RAS in clinical training for PD patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

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 Contact

Study Contact Backup

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (a) idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria;
  • (b) the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability;
  • (c) a score of Montreal Cognitive Assessment (MoCA) is equal to or higher than 21 to ensure that they understand experimental instructions;
  • (d) a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed;
  • (e) types and doses of medications remain unchanged in the past month right before participation.
  • Age- and sex-matched healthy controls who filled the criteria (c) and (d) will be recruited from communities.

Exclusion Criteria:

  • the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-RAS
training involving RAS
Behavioral: Upper-limb training involving RAS

Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient.

Patients will be asked to listen to the RAS sound, use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They should keep their movements consistent with the sound of the RAS, with one RAS sound corresponding to one pick-up movement.

Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.
Active Comparator: PD-noRAS
training without the aid of RAS
Behavioral: Upper-limb training without the aid of RAS

Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient.

Patients will be asked to use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They are asked to execute the task as fast as possible.

Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.
Experimental: HC-RAS
training involving RAS
Behavioral: Upper-limb training involving RAS

Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient.

Patients will be asked to listen to the RAS sound, use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They should keep their movements consistent with the sound of the RAS, with one RAS sound corresponding to one pick-up movement.

Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.
Active Comparator: HC-noRAS
training without the aid of RAS
Behavioral: Upper-limb training without the aid of RAS

Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient.

Patients will be asked to use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They are asked to execute the task as fast as possible.

Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography (EEG)
Time Frame: Assessments will be performed before the first day of training.
The power (unit:Watt) of EEG will be calculated.
Assessments will be performed before the first day of training.
Electroencephalography (EEG)
Time Frame: Assessments will be performed after the first day of training.
The power (unit:Watt) of EEG will be calculated.
Assessments will be performed after the first day of training.
Electroencephalography (EEG)
Time Frame: Assessments will be performed after the seven-day training program.
The power (unit:Watt) of EEG will be calculated.
Assessments will be performed after the seven-day training program.
Electroencephalography (EEG)
Time Frame: Assessments will be performed before the first day of training.
The functional connectivity (unit:coherence) of EEG will be calculated.
Assessments will be performed before the first day of training.
Electroencephalography (EEG)
Time Frame: Assessments will be performed after the first day of training.
The functional connectivity (unit:coherence) of EEG will be calculated.
Assessments will be performed after the first day of training.
Electroencephalography (EEG)
Time Frame: Assessments will be performed after the seven-day training program.
The functional connectivity (unit:coherence) of EEG will be calculated.
Assessments will be performed after the seven-day training program.
The box and block test (BBT)
Time Frame: Assessments will be performed before the first day of training.
The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
Assessments will be performed before the first day of training.
The box and block test (BBT)
Time Frame: Assessments will be performed after the first day of training.
The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
Assessments will be performed after the first day of training.
The box and block test (BBT)
Time Frame: Assessments will be performed after the seven-day training program.
The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
Assessments will be performed after the seven-day training program.
The nine hole peg test (NHPT)
Time Frame: Assessments will be performed before the first day of training.
The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.
Assessments will be performed before the first day of training.
The nine hole peg test (NHPT)
Time Frame: Assessments will be performed after the first day of training.
The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.
Assessments will be performed after the first day of training.
The nine hole peg test (NHPT)
Time Frame: Assessments will be performed after the seven-day training program.
The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.
Assessments will be performed after the seven-day training program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Wei FAN (PhD student), MSc, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

March 31, 2026

Study Completion (Anticipated)

March 31, 2026

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HongKongPU21037721r_20230221

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

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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