Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients

NCT ID: NCT05637593

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

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-12-31

Brief Summary

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The goal of this clinical trial is to examine effects of training involving rhythmic auditory stimulation (RAS) on upper-limb movements and functions in patients with Parkinson's disease (PD).

This study employed a 21-day randomized controlled trial design to evaluate the efficacy of upper-limb training involving RAS on upper-limb function and neural activity in PD patients. The RAS group showed sustained improvements at one-month follow-up.

Detailed Description

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This study employed a randomized controlled trial design. We randomly assigned PD patients into either the RAS group (experimental) or the noRAS group (control). Both groups underwent a 21-day training program (40 minutes per session, one session daily), with the only difference being the presence or absence of RAS. Assessments were conducted at five time points: baseline (T1), day 8 (T2), day 15 (T3), post-intervention (T4), and one-month follow-up (T5). Behavioral assessments were performed at all time points, while EEG recordings were only conducted at baseline (T1) and post-intervention (T4). All assessments and training sessions were scheduled during participants' medication 'on' state (1-2 hours after medication intake) to ensure consistency and optimal motor function.

Conditions

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Acoustic Stimulation Parkinson Disease Movement, Abnormal Bradykinesia Arm

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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the RAS group

The RAS group will receive upper-limb movement training with the aid of RAS;

Group Type EXPERIMENTAL

Upper-limb movement training with 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 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 21 days.

the no-RAS group

The no-RAS group will receive upper-limb movement training without the aid of RAS.

Group Type ACTIVE_COMPARATOR

Upper-limb movement 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 21 days.

Interventions

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Upper-limb movement training with 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 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 21 days.

Intervention Type BEHAVIORAL

Upper-limb movement 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 21 days.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria;
* the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability;
* a score of Montreal Cognitive Assessment is equal to or higher than 21 to ensure that they understand experimental instructions;
* a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed;
* types and doses of medications remain unchanged in the past month right before participation.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 (supervisor), PhD

Role: CONTACT

+852 27664197

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Other Identifiers

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HongKongPU21037721r_20221117

Identifier Type: -

Identifier Source: org_study_id

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