An interventional study of rhythmic auditory stimulation and No rhythm stimulation in Hemiplegia Due to Stroke, Parkinson Disease and Parkinsonian Syndrome, sponsored by YiCheng Zhu. Enrolling by invitation at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by YiCheng Zhu · Not applicable, Interventional, and Treatment
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
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →This is the only study on the registry with YiCheng Zhu as lead sponsor.
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For post-stroke hemiplegia
Inclusion criteria :
Exclusion Criteria:
For primary Parkinson's disease (PD)
Inclusion criteria:
Exclusion criteria:
For Parkinsonism syndrome:
Inclusion criteria:
Exclusion criteria:
Device: rhythmic auditory stimulation
Device: No rhythm 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.
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.
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
Time frame: 10 days
Stride length
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.
Time frame: 10 days
Stride frequency
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.
Time frame: 10 days
Stride speed
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.
Time frame: 10 days
Swing speed
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.
Time frame: 10 days
Standing phase
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.
Time frame: 10 days
Turn time
The difference between the turn time measured on the third day after the completion of the seven gait sessions and the baseline turn time.
Time frame: 10 days
Patient's SUBJECTIVE assessment
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.)
Time frame: 10 days
Resting-state functional magnetic resonance imaging
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).
Time frame: 10 days
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