Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders

YiCheng Zhu

Status

Invitation-only

Conditions

Parkinsonian Syndrome

Parkinson Disease

Hemiplegia Due to Stroke

Treatments

Device: rhythmic auditory stimulation

Device: No rhythm stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06837038

2022-PUMCH-D-007 (Other Grant/Funding Number)

K7442

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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