Clinical trial NCT06837038: Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders
Official title: Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hemiplegia Due to Stroke
Parkinson Disease
Parkinsonian Syndrome
Keywords: Rhythmic auditory stimulation
Hemiplegia after stroke
Parkinsonism syndrome
Gait disorders
Parkinson disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Gait speed
timeFrame: 10 days
Secondary outcomes:
measure: Stride length
timeFrame: 10 days
measure: Stride frequency
timeFrame: 10 days
measure: Stride speed
timeFrame: 10 days
measure: Swing speed
timeFrame: 10 days
measure: Standing phase
timeFrame: 10 days
measure: Turn time
timeFrame: 10 days
measure: Patient's SUBJECTIVE assessment
timeFrame: 10 days
measure: Resting-state functional magnetic resonance imaging
timeFrame: 10 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
name: Yicheng Zhu
role: STUDY_DIRECTOR
References: