Hemiplegia Due to StrokeNCT06837038
Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders
A study testing rhythmic auditory stimulation and No rhythm stimulation in people with Hemiplegia Due to Stroke and Parkinson Disease, run by YiCheng Zhu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hemiplegia Due to Stroke, Parkinson Disease, Parkinsonian Syndrome
- What is being tested?
- rhythmic auditory stimulation and No rhythm stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- No other rehabilitation treatment was received at present
- 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
- 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.
Who cannot join
- 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)
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- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100730
About this study
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.
Read more
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
- Being tested
- rhythmic auditory stimulation, No rhythm stimulation
- Keywords
- Rhythmic auditory stimulation, Hemiplegia after stroke, Parkinsonism syndrome, Gait disorders, Parkinson disease
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhythmic auditory stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Rhythm intervention group | Experimental | Not described Receives: Device: rhythmic auditory stimulation |
| Active control group | Sham comparator | Not described Receives: Device: No rhythm stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: 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).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Dec 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia Due to StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YiCheng Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YiCheng Zhu, Peking Union Medical College Hospital
- Investigators
- Yicheng Zhu, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837038
- Sponsor's protocol ID
- K7442
- Other IDs
- 2022-PUMCH-D-007
- Status last verified
- Dec 2024
- First submitted
- 5 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Rhythmic Auditory Stimulation for Gait Disorders
- ClinicalTrials.gov ID
- NCT06837038
- Acronym / sponsor ID
- K7442
- Keywords
- Rhythmic auditory stimulation, Hemiplegia after stroke, Parkinsonism syndrome, Gait disorders, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- YiCheng ZhuUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythm intervention group | Experimental | Device: rhythmic auditory stimulation |
| Active control group | Sham comparator | Device: No rhythm stimulation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhythmic auditory stimulationThe 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. | Device | Rhythm intervention group |
| No rhythm stimulationThe 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. | Device | Active control group |
Primary outcome
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
8 secondary outcomes
Stride length
Time frame: 10 days
Stride frequency
Time frame: 10 days
Stride speed
Time frame: 10 days
Swing speed
Time frame: 10 days
Standing phase
Time frame: 10 days
Turn time
Time frame: 10 days
Patient's SUBJECTIVE assessment
Time frame: 10 days
Resting-state functional magnetic resonance imaging
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Hemiplegia, Hemiplegia Due to Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yicheng Zhu study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhythmic auditory stimulation and No rhythm stimulation in people with Hemiplegia Due to Stroke and Parkinson Disease, run by YiCheng Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.