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 (18)

• 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.

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

• 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.

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

• 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.

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

• 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.

• 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.

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

• The Jebsen hand function test (JHFT)

  JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.

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

• The Jebsen hand function test (JHFT)

  JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.

  Day 8 (T2). During the training. JHFT takes approximately 15 minutes to administer.

• The Jebsen hand function test (JHFT)

  JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.

  Day 15 (T3). During the training. JHFT takes approximately 15 minutes to administer.

• The Jebsen hand function test (JHFT)

  JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.

  Post-intervention (T4). JHFT takes approximately 15 minutes to administer.

• The Jebsen hand function test (JHFT)

  JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.

  One-month follow-up (T5). JHFT takes approximately 15 minutes to administer.

• Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)

  The MDS-UPDRS evaluates various aspects of PD, including four parts: subjective non-motor experiences of daily living, subjective motor experiences of daily living, motor examination of the motor signs of PD, and motor complications based on historical and objective information. The scale is widely used in clinical settings as well as in research. We calculated the score of MDS-UPDRS Ⅲ, which is the motor examination of the motor signs, to assess the severity of bradykinesia.

  Baseline (T1). Before the training. MDS-UPDRS III takes approximately 15 minutes to administer.

• Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)

  The MDS-UPDRS evaluates various aspects of PD, including four parts: subjective non-motor experiences of daily living, subjective motor experiences of daily living, motor examination of the motor signs of PD, and motor complications based on historical and objective information. The scale is widely used in clinical settings as well as in research. We calculated the score of MDS-UPDRS Ⅲ, which is the motor examination of the motor signs, to assess the severity of bradykinesia.

  Post-intervention (T4). MDS-UPDRS III takes approximately 15 minutes to administer.

• Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)

  The MDS-UPDRS evaluates various aspects of PD, including four parts: subjective non-motor experiences of daily living, subjective motor experiences of daily living, motor examination of the motor signs of PD, and motor complications based on historical and objective information. The scale is widely used in clinical settings as well as in research. We calculated the score of MDS-UPDRS Ⅲ, which is the motor examination of the motor signs, to assess the severity of bradykinesia.

  One-month follow-up (T5). MDS-UPDRS III takes approximately 15 minutes to administer.

• The Nine-Hole Peg Test (NHPT)

  The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.

  Baseline (T1). Before the training. Before the training. NHPT takes approximately 5 minutes to administer.

• The Nine-Hole Peg Test (NHPT)

  The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.

  Day 8 (T2). During the training. NHPT takes approximately 5 minutes to administer.

• The Nine-Hole Peg Test (NHPT)

  The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.

  Day 15 (T3). During the training. NHPT takes approximately 5 minutes to administer.

• The Nine-Hole Peg Test (NHPT)

  The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.

  Post-intervention (T4). NHPT takes approximately 5 minutes to administer.

• The Nine-Hole Peg Test (NHPT)

  The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.

  One-month follow-up (T5). NHPT takes approximately 5 minutes to administer.

Secondary Outcomes (2)

• Electroencephalography (EEG)

  Baseline (T1). Before the training. It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.

• Electroencephalography (EEG)

  Post-intervention (T4). It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.

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 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

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

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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  PMID: 37438071 DERIVED

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: July 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2025
• Last Updated: April 22, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)