Acoustic StimulationNCT05637593
Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients
A study testing Upper-limb movement training with the aid of RAS and Upper-limb movement training without the aid of RAS in people with Acoustic Stimulation and Parkinson Disease, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acoustic Stimulation, Parkinson Disease, Movement, Abnormal
- What is being tested?
- Upper-limb movement training with the aid of RAS and Upper-limb movement training without the aid of RAS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Training Involving Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease
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.
Read the detailed description
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
- Acoustic Stimulation, Parkinson Disease, Movement, Abnormal, Bradykinesia, Arm
- Being tested
- Upper-limb movement training with the aid of RAS, Upper-limb movement training without the aid of RAS
- Medical subject headings
- Parkinson Disease, Dyskinesias, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper-limb movement training with the aid of RASBehavioural
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.
Upper-limb movement training without the aid of RASBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the RAS group | Experimental | The RAS group will receive upper-limb movement training with the aid of RAS; Receives: 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. Receives: Behavioral: Upper-limb movement training without the aid of RAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention (T4). BBT requires 8-10 minutes to administer.
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One-month follow-up (T5). JHFT 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One-month follow-up (T5). NHPT takes approximately 5 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.
Measured: 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.
Measured: 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.
Measured: One-month follow-up (T5). MDS-UPDRS III takes approximately 15 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.
Measured: 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.
Measured: Post-intervention (T4). It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Oct 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Acoustic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FAN Wei, The Hong Kong Polytechnic University
- Investigators
- Wei FAN (PhD student), MSc, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637593
- Sponsor's protocol ID
- HongKongPU21037721r_20221117
- Status last verified
- May 2026
- First submitted
- 24 Nov 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bengtsson SL, Ullen F, Ehrsson HH, Hashimoto T, Kito T, Naito E, Forssberg H, Sadato N. Listening to rhythms activates motor and premotor cortices. Cortex. 2009 Jan;45(1):62-71. doi: 10.1016/j.cortex.2008.07.002. Epub 2008 Oct 30.
PubMed 19041965Braunlich K, Seger CA, Jentink KG, Buard I, Kluger BM, Thaut MH. Rhythmic auditory cues shape neural network recruitment in Parkinson's disease during repetitive motor behavior. Eur J Neurosci. 2019 Mar;49(6):849-858. doi: 10.1111/ejn.14227. Epub 2018 Dec 3.
PubMed 30375083Buard I, Dewispelaere WB, Thaut M, Kluger BM. Preliminary Neurophysiological Evidence of Altered Cortical Activity and Connectivity With Neurologic Music Therapy in Parkinson's Disease. Front Neurosci. 2019 Feb 19;13:105. doi: 10.3389/fnins.2019.00105. eCollection 2019.
PubMed 30837830Cahn DA, Sullivan EV, Shear PK, Pfefferbaum A, Heit G, Silverberg G. Differential contributions of cognitive and motor component processes to physical and instrumental activities of daily living in Parkinson's disease. Arch Clin Neuropsychol. 1998 Oct;13(7):575-83.
PubMed 14590618Chen JL, Penhune VB, Zatorre RJ. Listening to musical rhythms recruits motor regions of the brain. Cereb Cortex. 2008 Dec;18(12):2844-54. doi: 10.1093/cercor/bhn042. Epub 2008 Apr 3.
PubMed 18388350Dalrymple-Alford JC, MacAskill MR, Nakas CT, Livingston L, Graham C, Crucian GP, Melzer TR, Kirwan J, Keenan R, Wells S, Porter RJ, Watts R, Anderson TJ. The MoCA: well-suited screen for cognitive impairment in Parkinson disease. Neurology. 2010 Nov 9;75(19):1717-25. doi: 10.1212/WNL.0b013e3181fc29c9.
PubMed 21060094Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
PubMed 8024419Dong VA, Fong KN, Chen YF, Tseng SS, Wong LM. 'Remind-to-move' treatment versus constraint-induced movement therapy for children with hemiplegic cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2017 Feb;59(2):160-167. doi: 10.1111/dmcn.13216. Epub 2016 Aug 9.
PubMed 27503605Fan W, Li J, Wei W, Xiao SH, Liao ZJ, Wang SM, Fong KNK. Effects of rhythmic auditory stimulation on upper-limb movements in patients with Parkinson's disease. Parkinsonism Relat Disord. 2022 Aug;101:27-30. doi: 10.1016/j.parkreldis.2022.06.020. Epub 2022 Jun 23.
PubMed 35763906Gale JT, Amirnovin R, Williams ZM, Flaherty AW, Eskandar EN. From symphony to cacophony: pathophysiology of the human basal ganglia in Parkinson disease. Neurosci Biobehav Rev. 2008;32(3):378-87. doi: 10.1016/j.neubiorev.2006.11.005. Epub 2007 Apr 26.
PubMed 17466375Ghai S, Ghai I, Schmitz G, Effenberg AO. Effect of rhythmic auditory cueing on parkinsonian gait: A systematic review and meta-analysis. Sci Rep. 2018 Jan 11;8(1):506. doi: 10.1038/s41598-017-16232-5.
PubMed 29323122Grahn JA, Rowe JB. Feeling the beat: premotor and striatal interactions in musicians and nonmusicians during beat perception. J Neurosci. 2009 Jun 10;29(23):7540-8. doi: 10.1523/JNEUROSCI.2018-08.2009.
PubMed 19515922Jastrzebowska MA, Marquis R, Melie-Garcia L, Lutti A, Kherif F, Herzog MH, Draganski B. Dopaminergic modulation of motor network compensatory mechanisms in Parkinson's disease. Hum Brain Mapp. 2019 Oct 15;40(15):4397-4416. doi: 10.1002/hbm.24710. Epub 2019 Jul 10.
PubMed 31291039Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available.
PubMed 5788487Koshimori Y, Thaut MH. Future perspectives on neural mechanisms underlying rhythm and music based neurorehabilitation in Parkinson's disease. Ageing Res Rev. 2018 Nov;47:133-139. doi: 10.1016/j.arr.2018.07.001. Epub 2018 Jul 10.
PubMed 30005957
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training Involving Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05637593
- Acronym / sponsor ID
- HongKongPU21037721r_20221117
- Conditions
- Acoustic Stimulation, Parkinson Disease, Movement, Abnormal, Bradykinesia, Arm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the RAS group | Experimental | Behavioral: Upper-limb movement training with the aid of RASThe RAS group will receive upper-limb movement training with the aid of RAS; |
| the no-RAS group | Active comparator | Behavioral: Upper-limb movement training without the aid of RASThe no-RAS group will receive upper-limb movement training without the aid of RAS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper-limb movement training with the aid of RASThree 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. | Behavioural | the RAS group |
| Upper-limb movement training without the aid of RASThree 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. | Behavioural | the no-RAS group |
Primary outcome
The box and block test (BBT)
Time frame: Post-intervention (T4). BBT requires 8-10 minutes to administer.
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.
19 secondary outcomes
The box and block test (BBT)
Time frame: Baseline (T1). Before the training. BBT requires 8-10 minutes to administer.
The box and block test (BBT)
Time frame: Day 8 (T2). During the training. BBT requires 8-10 minutes to administer.
The box and block test (BBT)
Time frame: Day 15 (T3). During the training. BBT requires 8-10 minutes to administer.
The box and block test (BBT)
Time frame: One-month follow-up (T5). BBT requires 8-10 minutes to administer.
The Jebsen hand function test (JHFT)
Time frame: Baseline (T1). Before the training. JHFT takes approximately 15 minutes to administer.
The Jebsen hand function test (JHFT)
Time frame: Day 8 (T2). During the training. JHFT takes approximately 15 minutes to administer.
The Jebsen hand function test (JHFT)
Time frame: Day 15 (T3). During the training. JHFT takes approximately 15 minutes to administer.
The Jebsen hand function test (JHFT)
Time frame: Post-intervention (T4). JHFT takes approximately 15 minutes to administer.
The Jebsen hand function test (JHFT)
Time frame: One-month follow-up (T5). JHFT takes approximately 15 minutes to administer.
The Nine-Hole Peg Test (NHPT)
Time frame: Baseline (T1). Before the training. Before the training. NHPT takes approximately 5 minutes to administer.
The Nine-Hole Peg Test (NHPT)
Time frame: Day 8 (T2). During the training. NHPT takes approximately 5 minutes to administer.
The Nine-Hole Peg Test (NHPT)
Time frame: Day 15 (T3). During the training. NHPT takes approximately 5 minutes to administer.
The Nine-Hole Peg Test (NHPT)
Time frame: Post-intervention (T4). NHPT takes approximately 5 minutes to administer.
The Nine-Hole Peg Test (NHPT)
Time frame: One-month follow-up (T5). NHPT takes approximately 5 minutes to administer.
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)
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)
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)
Time frame: One-month follow-up (T5). MDS-UPDRS III takes approximately 15 minutes to administer.
Electroencephalography (EEG)
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)
Time frame: Post-intervention (T4). It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 19041965Bengtsson SL, Ullen F, Ehrsson HH, Hashimoto T, Kito T, Naito E, Forssberg H, Sadato N. Listening to rhythms activates motor and premotor cortices. Cortex. 2009 Jan;45(1):62-71. doi: 10.1016/j.cortex.2008.07.002. Epub 2008 Oct 30.
- Background: PubMed 30375083Braunlich K, Seger CA, Jentink KG, Buard I, Kluger BM, Thaut MH. Rhythmic auditory cues shape neural network recruitment in Parkinson's disease during repetitive motor behavior. Eur J Neurosci. 2019 Mar;49(6):849-858. doi: 10.1111/ejn.14227. Epub 2018 Dec 3.
- Background: PubMed 30837830Buard I, Dewispelaere WB, Thaut M, Kluger BM. Preliminary Neurophysiological Evidence of Altered Cortical Activity and Connectivity With Neurologic Music Therapy in Parkinson's Disease. Front Neurosci. 2019 Feb 19;13:105. doi: 10.3389/fnins.2019.00105. eCollection 2019.
- Background: PubMed 14590618Cahn DA, Sullivan EV, Shear PK, Pfefferbaum A, Heit G, Silverberg G. Differential contributions of cognitive and motor component processes to physical and instrumental activities of daily living in Parkinson's disease. Arch Clin Neuropsychol. 1998 Oct;13(7):575-83.
- Background: PubMed 18388350Chen JL, Penhune VB, Zatorre RJ. Listening to musical rhythms recruits motor regions of the brain. Cereb Cortex. 2008 Dec;18(12):2844-54. doi: 10.1093/cercor/bhn042. Epub 2008 Apr 3.
- Background: PubMed 21060094Dalrymple-Alford JC, MacAskill MR, Nakas CT, Livingston L, Graham C, Crucian GP, Melzer TR, Kirwan J, Keenan R, Wells S, Porter RJ, Watts R, Anderson TJ. The MoCA: well-suited screen for cognitive impairment in Parkinson disease. Neurology. 2010 Nov 9;75(19):1717-25. doi: 10.1212/WNL.0b013e3181fc29c9.
- Background: PubMed 8024419Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
- Background: PubMed 27503605Dong VA, Fong KN, Chen YF, Tseng SS, Wong LM. 'Remind-to-move' treatment versus constraint-induced movement therapy for children with hemiplegic cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2017 Feb;59(2):160-167. doi: 10.1111/dmcn.13216. Epub 2016 Aug 9.
- Background: PubMed 35763906Fan W, Li J, Wei W, Xiao SH, Liao ZJ, Wang SM, Fong KNK. Effects of rhythmic auditory stimulation on upper-limb movements in patients with Parkinson's disease. Parkinsonism Relat Disord. 2022 Aug;101:27-30. doi: 10.1016/j.parkreldis.2022.06.020. Epub 2022 Jun 23.
- Background: PubMed 17466375Gale JT, Amirnovin R, Williams ZM, Flaherty AW, Eskandar EN. From symphony to cacophony: pathophysiology of the human basal ganglia in Parkinson disease. Neurosci Biobehav Rev. 2008;32(3):378-87. doi: 10.1016/j.neubiorev.2006.11.005. Epub 2007 Apr 26.
- Background: PubMed 29323122Ghai S, Ghai I, Schmitz G, Effenberg AO. Effect of rhythmic auditory cueing on parkinsonian gait: A systematic review and meta-analysis. Sci Rep. 2018 Jan 11;8(1):506. doi: 10.1038/s41598-017-16232-5.
- Background: PubMed 19515922Grahn JA, Rowe JB. Feeling the beat: premotor and striatal interactions in musicians and nonmusicians during beat perception. J Neurosci. 2009 Jun 10;29(23):7540-8. doi: 10.1523/JNEUROSCI.2018-08.2009.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei FAN (PhD student), MSc principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper-limb movement training with the aid of RAS and Upper-limb movement training without the aid of RAS in people with Acoustic Stimulation and Parkinson Disease, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The box and block test (BBT) (time frame: Post-intervention (T4). BBT requires 8-10 minutes to administer.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637593, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.