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NCT Number: NCT06837038

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

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Key information

Conditions

Hemiplegia Due to Stroke Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mobility Limitation Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Parkinsonian Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rhythmic auditory stimulation

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.

No rhythm stimulation

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.

Primary outcomes

  1. Gait speed

    Time frame: 10 days

    The difference between the gait speed measured on the third day after the completion of the seven gait sessions and the baseline gait speed

Secondary outcomes

  1. Stride length

    Time frame: 10 days

    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.

  2. Stride frequency

    Time frame: 10 days

    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.

  3. Stride speed

    Time frame: 10 days

    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.

  4. Swing speed

    Time frame: 10 days

    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.

  5. Standing phase

    Time frame: 10 days

    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.

  6. Turn time

    Time frame: 10 days

    The difference between the turn time measured on the third day after the completion of the seven gait sessions and the baseline turn time.

  7. Patient's SUBJECTIVE assessment

    Time frame: 10 days

    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.)

  8. Resting-state functional magnetic resonance imaging

    Time frame: 10 days

    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).

Sponsors and collaborators

Lead sponsor

YiCheng Zhu

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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