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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
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.
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One-month follow-up (T5). NHPT takes approximately 5 minutes to administer.
Electroencephalography (EEG)
EEG recordings were conducted using a clinical-grade Nicolet Monitor system (Natus Medical Incorporated, USA). The system features comprehensive neurophysiological monitoring capabilities with high signal-to-noise ratio and stable recording characteristics. We employed a standard 19-electrode montage following the international 10-20 system, ensuring precise and reproducible electrode positioning based on anatomical landmarks.
Time frame: Baseline (T1). Before the training. It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.
Electroencephalography (EEG)
EEG recordings were conducted using a clinical-grade Nicolet Monitor system (Natus Medical Incorporated, USA). The system features comprehensive neurophysiological monitoring capabilities with high signal-to-noise ratio and stable recording characteristics. We employed a standard 19-electrode montage following the international 10-20 system, ensuring precise and reproducible electrode positioning based on anatomical landmarks.
Time frame: Post-intervention (T4). It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.
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