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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-PUMCH-D-007 | Other Grant/Funding Number | Clinical research program of the central high-level hospital |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhythm intervention group | Experimental |
| |
| Active control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 days |
| Stride frequency |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Yicheng Zhu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
|
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.
| 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. | 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. | 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. | 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. | 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.) | 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). | 10 days |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |