Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients

NCT05637593 | Completed

• 1 other identifier: HongKongPU21037721r_20221117
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acoustic Stimulation; Parkinson Disease; Movement, Abnormal; Bradykinesia; Arm

Outcome Measures

Primary Outcomes (1)

• The box and block test (BBT)

  BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7\* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.

  Post-intervention (T4). BBT requires 8-10 minutes to administer.

Secondary Outcomes (19)

• The box and block test (BBT)

  Baseline (T1). Before the training. BBT requires 8-10 minutes to administer.

• The box and block test (BBT)

  Day 8 (T2). During the training. BBT requires 8-10 minutes to administer.

• The box and block test (BBT)

  Day 15 (T3). During the training. BBT requires 8-10 minutes to administer.

• The box and block test (BBT)

  One-month follow-up (T5). BBT requires 8-10 minutes to administer.

• The Jebsen hand function test (JHFT)

  Baseline (T1). Before the training. JHFT takes approximately 15 minutes to administer.

Study Arms (2)

the RAS group

EXPERIMENTAL

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

Behavioral: Upper-limb movement training with the aid of RAS

the no-RAS group

ACTIVE COMPARATOR

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

Behavioral: Upper-limb movement training without the aid of RAS

Interventions

Upper-limb movement training without the aid of RAS 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.

the no-RAS group

Upper-limb movement training with the aid of RAS 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 RAS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Wuhan Brain Hospital

Wuhan, Hubei, 41000, China

Location

Related Publications (34)

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MeSH Terms

Conditions

Parkinson Disease; Dyskinesias; Hypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei FAN (PhD student), MSc

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 5, 2022
• Study Start: October 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)