Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders

Overview

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

Interventions

• 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.
• 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.

Primary outcome measures

• Gait speed [Time frame: 10 days]

Secondary outcome measures (8)

• Stride length [Time frame: 10 days]
• Stride frequency [Time frame: 10 days]
• Stride speed [Time frame: 10 days]
• Swing speed [Time frame: 10 days]
• Standing phase [Time frame: 10 days]
• Turn time [Time frame: 10 days]
• Patient's SUBJECTIVE assessment [Time frame: 10 days]
• Resting-state functional magnetic resonance imaging [Time frame: 10 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical — Beijing

Identifiers

NCT: NCT06837038 · K7442 · 2022-PUMCH-D-007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗