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

NCT ID: NCT05782322

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acoustic Stimulation Parkinson Disease Electroencephalography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD-RAS

training involving RAS

Group Type EXPERIMENTAL

Upper-limb training involving RAS

Intervention Type BEHAVIORAL

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.

PD-noRAS

training without the aid of RAS

Group Type ACTIVE_COMPARATOR

Upper-limb training without the aid of RAS

Intervention Type BEHAVIORAL

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.

HC-RAS

training involving RAS

Group Type EXPERIMENTAL

Upper-limb training involving RAS

Intervention Type BEHAVIORAL

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.

HC-noRAS

training without the aid of RAS

Group Type ACTIVE_COMPARATOR

Upper-limb training without the aid of RAS

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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FAN Wei

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei FAN (PhD student), MSc

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Central Contacts

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Wei FAN (PhD student), MSc

Role: CONTACT

+825 67681229

Shu-Mei Wang, PhD

Role: CONTACT

+852 27664197

References

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Other Identifiers

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HongKongPU21037721r_20230221

Identifier Type: -

Identifier Source: org_study_id

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