Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders

NCT06837038 | Enrolling By Invitation

• 2 other identifiers: K74422022-PUMCH-D-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Rhythmic auditory stimulation; Hemiplegia after stroke; Parkinsonism syndrome; Gait disorders; Parkinson disease

Outcome Measures

Primary Outcomes (1)

• Gait speed

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

  10 days

Secondary Outcomes (8)

• Stride length

  10 days

• Stride frequency

  10 days

• Stride speed

  10 days

• Swing speed

  10 days

• Standing phase

  10 days

Study Arms (2)

Rhythm intervention group

EXPERIMENTAL

Device: rhythmic auditory stimulation

Active control group

SHAM COMPARATOR

Device: No rhythm stimulation

Interventions

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.

Rhythm intervention group

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.

Active control group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• m/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

You may not qualify if:

• 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)
• 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
• m/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
• Unable to cooperate with the motor function test

Sponsors & Collaborators

• YiCheng Zhu: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Mobility Limitation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yicheng Zhu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project Leader

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 20, 2025
• Study Start: December 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 20, 2025

Record last verified: 2024-12

Locations

CN (1)