Parkinson DiseaseNCT06147713
Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
A study testing Vibrotactile foot device (Smart shoe) in people with Parkinson Disease and Freezing of Gait, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Freezing of gait (FOG) is a common, disabling symptom of later stage Parkinson's disease (PD), and can induce significant morbidity and mortality by increasing risk of falls as the disease progresses. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease, Freezing of Gait
- What is being tested?
- Vibrotactile foot device (Smart shoe)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-80 years
- Diagnosed with Parkinson's Disease according to MDS Clinical Diagnostic Criteria
- Stable drug therapy without any change in the past one month
- Subjective presence of FOG more than once per day
- Objective presence of FOG by provoking tasks, e.g., gait initiation, rapid full turn, et al.
- Able to walk unaided at least 20 meters
- Provide written informed consent
Who cannot join
- Stroke and other diseases interfering ambulation
- Severe foot sensory impairments disabling the individual to perceive vibratory stimulation
- History of deep brain stimulation surgery
Trial locations and contacts
1 site in 1 country.
Shanshan Cen, MD. PhD. contact
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing
Piu Chan, MD.,PhD., +86-010-83198677, pbchan@hotmail.com
About this study
Freezing of gait (FOG) is a common, disabling symptom of later stage Parkinson's disease (PD), and can induce significant morbidity and mortality by increasing risk of falls as the disease progresses. Despite optimum medical management and deep brain stimulation therapy, many patients with PD are incapacitated by FOG and gait disorders. Non-invasive vibrotactile stimulation has been reported to potentially improve FOG of patients with PD. However, results of studies were variable, and there is a lack of convenient vibrotactile devices ready for daily use with reliable clinical trial data. In the proposed study, the investigator will test the effect of a newly developed vibrotactile foot device (Smart shoe) on participants diagnosed with PD and FOG. EEG and fMRI are obtained in order to investigate the underlying neurological mechanism.
- Conditions
- Parkinson Disease, Freezing of Gait
- Being tested
- Vibrotactile foot device (Smart shoe)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile foot device (Smart shoe)Device
A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The subjects will be examined during the drug-off period with the vibrotactile foot device off and on at different patterns. The tests will be carried out during the onsite clinical visits on the day of initial enrollment and two weeks after home wearing. Receives: Device: Vibrotactile foot device (Smart shoe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Freezing of Gait Questionnaire (NFOGQ)
Changes in the New Freezing of Gait Questionnaire (NFOGQ) score
Measured: 2 weeks
Freezing severity
Changes in the quantified freezing severity during walking task, videotape reviewed by movement disorder specialists
Measured: 2 weeks
Secondary outcomes (6)
Quantitative Gait parameters
Changes in gait parameters such as stride length, et al. during walking tasks
Measured: 2 weeks
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
Changes in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score
Measured: 2 weeks
Berg Balance Scale
Changes in the Berg Balance Scale score
Measured: 2 weeks
Number of falls and near falls
Changes in number of falls and near falls during intervention period
Measured: 2 weeks
39-item Parkinson's Disease Questionnaire (PDQ-39)
Changes in the 39-item Parkinson's Disease Questionnaire (PDQ-39) score
Measured: 2 weeks
Clinical Global Impressions Scale (CGI-I)
Changes in the Clinical Global Impressions Scale (CGI-I) score
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 May 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147713
- Sponsor's protocol ID
- Vibrotactile Foot Device
- Status last verified
- Aug 2023
- First submitted
- 14 Nov 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06147713
- Acronym / sponsor ID
- Vibrotactile Foot Device
- Conditions
- Parkinson Disease, Freezing of Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 28 Nov 2023 (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.
Freezing of gait (FOG) is a common, disabling symptom of later stage Parkinson's disease (PD), and can induce significant morbidity and mortality by increasing risk of falls as the disease progresses. Despite optimum medical management and deep brain stimulation therapy, many patients with PD are incapacitated by FOG and gait disorders. Non-invasive vibrotactile stimulation has been reported to potentially improve FOG of patients with PD. However, results of studies were variable, and there is a lack of convenient vibrotactile devices ready for daily use with reliable clinical trial data. In the proposed study, the investigator will test the effect of a newly developed vibrotactile foot device (Smart shoe) on participants diagnosed with PD and FOG. EEG and fMRI are obtained in order to investigate the underlying neurological mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Vibrotactile foot device (Smart shoe)The subjects will be examined during the drug-off period with the vibrotactile foot device off and on at different patterns. The tests will be carried out during the onsite clinical visits on the day of initial enrollment and two weeks after home wearing. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 30-80 years
- Diagnosed with Parkinson's Disease according to MDS Clinical Diagnostic Criteria
- Stable drug therapy without any change in the past one month
- Subjective presence of FOG more than once per day
- Objective presence of FOG by provoking tasks, e.g., gait initiation, rapid full turn, et al.
Key exclusion criteria (3 listed)
- Stroke and other diseases interfering ambulation
- Severe foot sensory impairments disabling the individual to perceive vibratory stimulation
- History of deep brain stimulation surgery
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 |
|---|---|---|
| Vibrotactile foot device (Smart shoe)A foot device deliver vibrotactile stimulation triggered by a foot pressure sensor. | Device | Intervention |
Primary outcome
New Freezing of Gait Questionnaire (NFOGQ)
Time frame: 2 weeks
Changes in the New Freezing of Gait Questionnaire (NFOGQ) score
Freezing severity
Time frame: 2 weeks
Changes in the quantified freezing severity during walking task, videotape reviewed by movement disorder specialists
6 secondary outcomes
Quantitative Gait parameters
Time frame: 2 weeks
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
Time frame: 2 weeks
Berg Balance Scale
Time frame: 2 weeks
Number of falls and near falls
Time frame: 2 weeks
39-item Parkinson's Disease Questionnaire (PDQ-39)
Time frame: 2 weeks
Clinical Global Impressions Scale (CGI-I)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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. This study is not recruiting at the moment.
Shanshan Cen, MD. PhD. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile foot device (Smart shoe) in people with Parkinson Disease and Freezing of Gait, run by Xuanwu Hospital, Beijing 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piu Chan, MD. PhD. (+86-010-83198677, pbchan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Freezing of Gait Questionnaire (NFOGQ) (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 2 Feb 2024.