Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders

NCT ID: NCT06837038

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-10-31

Brief Summary

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

Conditions

Hemiplegia Due to Stroke; Parkinson Disease; Parkinsonian Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rhythm intervention group

Group Type: EXPERIMENTAL

rhythmic auditory stimulation

Intervention Type: DEVICE

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.

Active control group

Group Type: SHAM_COMPARATOR

No rhythm stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• 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.
• 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)

• 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:

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YiCheng Zhu

OTHER

Sponsor Role: lead

Responsible Party

YiCheng Zhu

Project Leader

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yicheng Zhu

Role: STUDY_DIRECTOR

Locations

Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2022-PUMCH-D-007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

K7442

Identifier Type: -

Identifier Source: org_study_id