Effects and Mechanisms of RAS Training on Upper-limb Movements in PD Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Hong Kong Polytechnic University
About this trial
Introduction Bradykinesia (i.e., slow movements) is one of the most prominent symptoms of Parkinson's disease (PD) and has a negative impact on quality of life. Rhythmic auditory stimulation (RAS), a widely used and promising treatment technique, has been shown to effectively improve gait speed in PD patients. However, only few studies have explored effects and neural mechanisms of RAS on upper-limb movements. We will conduct two studies to investigate effects and mechanisms of RAS on upper-limb movements in PD patients. The purpose of this study is to examine effects and neural mechanisms of upper-limb movement training involving RAS in PD patients.
Methods This study will recruit patients with PD and healthy controls. This study will randomly assign PD patients into two groups: the PD-RAS group and the PD-noRAS group, and healthy controls into the HC-RAS group and the HC-noRAS group. A 7-day upper-limb training involving RAS (for the PD-RAS group and the HC-RAS group) or without RAS (for the PD-noRAS group and the HC-noRAS group) will be provided. EEG and behavioral assessments will be conducted before and after the first day of training, and after the seven-day training program. Two-way repeated measures analysis of variance will be performed to investigate the group and time effects on upper-limb function and neural activity.
Study significance The training program will serve as a reference for clinical practitioners who are interested in using RAS in clinical training for PD patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
(a) idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria;
(b) the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability;
(c) a score of Montreal Cognitive Assessment (MoCA) is equal to or higher than 21 to ensure that they understand experimental instructions;
(d) a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed;
Disqualifiers
the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
Trial design
Design model
Parallel
Treatments tested in this trial
Upper-limb training involving RAS
BehavioralThree 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 7 days.
Upper-limb training without the aid of RAS
BehavioralThree 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 7 days.
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: PD-RASExperimental treatment 1 intervention
Group B: PD-noRASActive comparator 1 intervention
Group C: HC-RASExperimental treatment 1 intervention
Group D: HC-noRASActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Electroencephalography (EEG)
The power (unit:Watt) of EEG will be calculated.
Time frame
Assessments will be performed before the first day of training.2
Electroencephalography (EEG)
The power (unit:Watt) of EEG will be calculated.
Time frame
Assessments will be performed after the seven-day training program.3
Electroencephalography (EEG)
The functional connectivity (unit:coherence) of EEG will be calculated.
Time frame
Assessments will be performed before the first day of training.4
Electroencephalography (EEG)
The functional connectivity (unit:coherence) of EEG will be calculated.
Time frame
Assessments will be performed after the seven-day training program.Secondary outcomes
1
The Jebsen Hand Function Test (JHFT)
The Jebsen Hand Function Test (JHFT) evaluated unimanual performance in activities of daily living through six standardized tasks: card turning, small object manipulation, simulated feeding, checker stacking, and moving both light and heavy objects. We modified the original seven-item test by excluding the writing task to accommodate Chinese-speaking participants, following established protocols for cross-cultural adaptation. Performance was measured by completion time for each task, with shorter times indicating better hand function. The JHFT demonstrates excellent test-retest reliability in PD patients (intraclass correlation coefficients: 0.89-0.97).
Time frame
Assessments will be performed before the first day of training.2
The Jebsen Hand Function Test (JHFT)
The Jebsen Hand Function Test (JHFT) evaluated unimanual performance in activities of daily living through six standardized tasks: card turning, small object manipulation, simulated feeding, checker stacking, and moving both light and heavy objects. We modified the original seven-item test by excluding the writing task to accommodate Chinese-speaking participants, following established protocols for cross-cultural adaptation. Performance was measured by completion time for each task, with shorter times indicating better hand function. The JHFT demonstrates excellent test-retest reliability in PD patients (intraclass correlation coefficients: 0.89-0.97).
Time frame
Assessments will be performed after the 7-day training.3
Ruler Drop Test (RDT)
We assessed reaction time using the Ruler Drop Test (RDT). During this test, a ruler was positioned vertically between the participant's thumb and index finger, with its zero mark aligned at the fingertips. Following a ready signal from the participant, the examiner released the ruler without warning, requiring the participant to catch it as quickly as possible upon visual detection of movement. The falling distance was recorded, with greater distances indicating longer reaction times. The test was repeated three times, and the average distance was calculated. This measure reflects neuromotor processing speed, encompassing both visual information processing and movement initiation time.
Time frame
Assessments will be performed before the first day of training.4
Ruler Drop Test (RDT)
We assessed reaction time using the Ruler Drop Test (RDT). During this test, a ruler was positioned vertically between the participant's thumb and index finger, with its zero mark aligned at the fingertips. Following a ready signal from the participant, the examiner released the ruler without warning, requiring the participant to catch it as quickly as possible upon visual detection of movement. The falling distance was recorded, with greater distances indicating longer reaction times. The test was repeated three times, and the average distance was calculated. This measure reflects neuromotor processing speed, encompassing both visual information processing and movement initiation time.
Time frame
Assessments will be performed after the 7-day training.Locations
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Source ClinicalTrials.gov
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