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Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders

Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06837038
Enrollment
60
Registered
2025-02-20
Start date
2024-12-01
Completion date
2025-10-31
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia Due to Stroke, Parkinson Disease, Parkinsonian Syndrome

Keywords

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

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

Interventions

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.

DEVICENo 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.

Sponsors

YiCheng Zhu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Gait speed10 daysThe difference between the gait speed measured on the third day after the completion of the seven gait sessions and the baseline gait speed

Secondary

MeasureTime frameDescription
Stride frequency10 daysThe 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.
Stride speed10 daysThe 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.
Swing speed10 daysThe 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.
Stride length10 daysThe 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.
Turn time10 daysThe difference between the turn time measured on the third day after the completion of the seven gait sessions and the baseline turn time.
Patient's SUBJECTIVE assessment10 daysAll 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.)
Resting-state functional magnetic resonance imaging10 daysAt 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).
Standing phase10 daysThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026