Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders

The aim of this clinical trial was to determine whether rhythmic auditory stimulation is effective in treating gait disorders in patients with post-stroke hemiplegia, primary Parkinson's disease, and various parkinsonism syndromes. The main questions it aims to answer are:

Does rhythmic auditory stimulation increase walking speed in patients with gait disorders? To determine whether rhythmic auditory stimulation is effective in treating gait disorders, researchers will compare a gait rhythmometer with an active control that does not receive rhythmic stimulation.

Participants will:

Gait training was conducted once a day for 15 minutes for 7 consecutive days Resting-state functional magnetic resonance imaging (fmri) was performed before and after treatment Feedback on subjective improvement at the end of the 7-day treatment

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease; Parkinsonian Syndrome; Hemiplegia Due to Stroke
• Intervention / Treatment: Device: rhythmic auditory stimulation; Device: No rhythm stimulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

For post-stroke hemiplegia

Inclusion criteria :

• Age 50-80 years old
• One or more strokes (cerebral infarction or cerebral hemorrhage), with the most recent stroke occurring at least 6 months earlier
• Walking independently without a cane or walking aid with obvious gait asymmetry
• 0.4m/s< baseline velocity <0.8m/s
• Sufficient hearing, vision and comprehension to complete motor function tests
• Patients were willing and able to participate in all study procedures and signed informed consent
• No other rehabilitation treatment was received at present

Exclusion Criteria:

• Unable to cooperate with the motor function test
• Uncontrolled hypertension
• Myocardial infarction within the past 3 months
• With bone and joint diseases, such as a history of lower limb fracture within 1 year, waist and lower limb bone and joint surgery, bone and joint deformity seriously affecting walking, etc.
• Except for stroke, there was no parkinsonism, myasthenia gravis, poliomyelitis and other nervous system diseases affecting the walking function of patients.

For primary Parkinson's disease (PD)

Inclusion criteria:

• Age 50-80 years old
• PD met the diagnostic criteria of Chinese Diagnostic Criteria for Parkinson's Disease (2016 edition)
• Obvious panic gait, freezing gait or slow gait, but can walk independently without the use of a cane or walking aid
• Hoehn-Yahr (H-Y) stage 2-4
• 0.4m/s< baseline velocity <0.8m/s
• Sufficient hearing, vision and comprehension to complete motor function tests
• Patients were willing and able to participate in all study procedures and signed informed consent
• No other rehabilitation treatment was received at present

Exclusion criteria:

• Unable to cooperate with the motor function test
• Uncontrolled hypertension
• Myocardial infarction within the past 3 months
• With bone and joint diseases, such as a history of lower limb fracture within 1 year, waist and lower limb bone and joint surgery, bone and joint deformity seriously affecting walking, etc
• There was no stroke, myasthenia gravis, poliomyelitis and other neurological diseases affecting the walking function except for primary Parkinson's disease

For Parkinsonism syndrome:

Inclusion criteria:

• Age 50-80 years old
• All parkinsonism syndrome except primary Parkinson's disease, including but not limited to drug-induced parkinsonism, multiple system atrophy, cerebral small vessel disease-related parkinsonism, etc
• obvious panic gait, freezing gait or slow gait, but can walk independently without the use of a cane or walking aid
• 0.4m/s< baseline velocity <0.8m/s
• Sufficient hearing, vision and comprehension to complete motor function tests
• Be willing and able to participate in all study procedures and sign informed consent
• No other rehabilitation treatment was received at present.

Exclusion criteria:

• Unable to cooperate with the motor function test
• Uncontrolled hypertension
• Myocardial infarction within the past 3 months
• With bone and joint diseases, such as a history of lower limb fracture within 1 year, waist and lower limb bone and joint surgery, bone and joint deformity seriously affecting walking, etc
• There was no stroke, myasthenia gravis, poliomyelitis and other neurological diseases that affected the walking function except for parkinsonism

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhythm intervention group	Device: rhythmic auditory stimulation; The intervention group was treated with a gait rhythm device under the supervision of the researchers. The complete gait training was conducted once a day for 15 minutes for 7 consecutive days. Each patient wore inertial sensors at both ankles during gait training to collect gait information during walking.
Sham Comparator: Active control group	Device: No rhythm stimulation; The control group received gait training without rhythmic auditory stimulation under the supervision of the researchers. The complete gait training was conducted once a day for 15 to 20 minutes for 7 consecutive days. Each patient wore inertial sensors at both ankles during gait training to collect gait information during walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	The difference between the gait speed measured on the third day after the completion of the seven gait sessions and the baseline gait speed	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stride length	The difference between the stride length (left and right) measured on the third day after the completion of the seven gait sessions and the baseline stride length.	10 days
Stride frequency	The difference between the stride frequency (left and right) measured on the third day after the completion of the seven gait sessions and the baseline stride frequency.	10 days
Stride speed	The difference between the stride speed (left and right) measured on the third day after the completion of the seven gait sessions and the baseline stride speed.	10 days
Swing speed	The difference between the swing speed (left and right) measured on the third day after the completion of the seven gait sessions and the baseline swing speed.	10 days
Standing phase	The difference between the standing phase (left and right) measured on the third day after the completion of the seven gait sessions and the baseline standing phase.	10 days
Turn time	The difference between the turn time measured on the third day after the completion of the seven gait sessions and the baseline turn time.	10 days
Patient's SUBJECTIVE assessment	All subjects were asked about their subjective feelings using a uniform questionnaire, including the following questions: Did the patient's gait problems improve after 7 days of treatment? If there has been improvement, in what ways? (Step speed, stride length, symmetry, turn time, etc.)	10 days
Resting-state functional magnetic resonance imaging	At baseline and on the third day after completion of the 7-day gait treatment, 3T resting-state functional magnetic resonance imaging (rs-fMRI) was performed to compare the changes of local neural activity, including amplitude of low frequency fluctuation (ALFF) and functional connectivity density (FCD).	10 days

Collaborators and Investigators

• Sponsor: YiCheng Zhu
• Investigators: Study Director: Yicheng Zhu

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson disease; Rhythmic auditory stimulation; Gait disorders; Hemiplegia after stroke; Parkinsonism syndrome
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Paralysis; Parkinson Disease; Parkinsonian Disorders; Hemiplegia
• Other Study ID Numbers: K7442; 2022-PUMCH-D-007 (Other Grant/Funding Number: Clinical research program of the central high-level hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No