Parkinson DiseaseNCT01772186
Freezing of Gait Correction and Fall Prevention: Developing a Real-time Somatosensory Stimulation System
A study testing Real-time somatosensory cue in people with Parkinson Disease, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in people with Parkinson's disease (PD), and closely associates with postural instability and fall. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Real-time somatosensory cue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTaiwan
- Study dates
- Feb 2013to Jul 2014
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinsonian with Hoehn-Yahr score between 2 to 4
- Suffering freezing-of-gait in the recent week
- Able to walk unassisted over 30 meters in medication OFF period
Who cannot join
- Non-idiopathic Parkinsonian
- Comorbid with uncontrolled neurological, cardiovascular and orthopedic diseases that might affect balance and mobility
- Impaired cognitive function
- Abnormal plantar sensory function
- Abnormal coagulation function
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Ruey-Meei Wu, Professor, 886-2-23123456 ext. 2144, robinwu@ntu.edu.tw
Wen-Chieh Yang, Ph.D. student, 886-2-33668149, d98428003@ntu.edu.tw
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ruey-Meei Wu, Professor, 886-2-23123456 ext. 2144, robinwu@ntu.edu.tw
Wen-Chieh Yang, Ph.D. student, 886-2-33668149, d98428003@ntu.edu.tw
About this study
Official title: Freezing of Gait Correction and Fall Prevention in People With Parkinson's Disease: Developing and Application of a Real-time Somatosensory Stimulation System
Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in people with Parkinson's disease (PD), and closely associates with postural instability and fall. Previous studies had shown that somatosensory stimulation could induce weight shift, and this is probably helpful for gait reinitiation. Therefore, the investogators propose a two-year project to develop a wearable device, the somatosensory stimulation system (SSS), which monitors gait real-time and provide somatosensory stimulation once FOG episodes detected. And the investigators test the effects of this SSS device on FOG, fall, and walking function.
Methods: The first-year study is to build and validate this wearable SSS device. The customized device has sensor part and stimulator part; the former is an inertial sensor module to detect FOG episodes, and the latter is a microvibrator-embedded insole to facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are recruited and conduct FOG-provoking tasks during their medication "OFF" or "late On" state in a laboratory setting. The investigators test if the SSS device could facilitate lateral weight shift and help gait reinitiation, as well as the reliability. The second-year study is to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its effect on FOG, fall, and walking function. The investigators recruit PD patients with FOG, and randomly assign them into the experimental and control groups. Both groups wear the SSS device during the daytime for ten weeks, and the stimulator part is turned on during the first six weeks (intervention phase) only in the experimental group. The stimulator part is then kept off during the last four weeks (follow-up phase) in both groups. The effect of the SSS device is evaluated by the outcomes including FOG severity, fall and walking function, which are measured prior/after the intervention phase and after the follow-up phase.
Clinical relevance: This project tempts to combine real-time gait analysis with somatosensory-induced postural readjustment, and using this novel approach to improve FOG and fall in people with PD. The results of this projects might also provide an objective, long-term assessment tool to measure the FOG phenomenon for clinical and research fields.
- Conditions
- Parkinson Disease
- Being tested
- Real-time somatosensory cue
- Keywords
- Freezing of gait, Parkinson's disease, Somatosensory stimulation, Fall prevention
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time somatosensory cueDevice
A novel sensory cue proposed in this study, which designed to facilitate weight shift during freezing-of-gait episodes. This sensory cue is controlled by the real-time analysis of gait pattern, and given only when freezing-of-gait detected.
| Study group | Role | What they receive |
|---|---|---|
| Without real-time somatosensory cue | No intervention | Parkinson patients wear the somatosensory stimulation system but not receive the real-time somatosensory cue during freezing-of-gait episodes. |
| With real-time somatosensory cue | Experimental | Parkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes. Receives: Device: Real-time somatosensory cue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the somatosensory stimulation system
The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
Measured: 2 weeks
Validity of the somatosensory stimulation system
If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
Measured: 2 weeks
Fall prevention
If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2014 (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 National Taiwan University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Ruey-Meei Wu, Professor, Principal investigator, Department of Neurology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, TaiwanKwan-Hwa Lin, Professor, Principal investigator, Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772186
- Sponsor's protocol ID
- 201112158DIB
- Status last verified
- Oct 2013
- First submitted
- 17 Jan 2013
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freezing of Gait Correction and Fall Prevention in People With Parkinson's Disease: Developing and Application of a Real-time Somatosensory Stimulation System
- ClinicalTrials.gov ID
- NCT01772186
- Acronym / sponsor ID
- 201112158DIB
- Conditions
- Parkinson Disease
- Keywords
- Freezing of gait, Parkinson's disease, Somatosensory stimulation, Fall prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (estimated)
- First posted
- 21 Jan 2013 (estimated)
- 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.
Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in people with Parkinson's disease (PD), and closely associates with postural instability and fall. Previous studies had shown that somatosensory stimulation could induce weight shift, and this is probably helpful for gait reinitiation. Therefore, the investogators propose a two-year project to develop a wearable device, the somatosensory stimulation system (SSS), which monitors gait real-time and provide somatosensory stimulation once FOG episodes detected. And the investigators test the effects of this SSS device on FOG, fall, and walking function.
Methods: The first-year study is to build and validate this wearable SSS device. The customized device has sensor part and stimulator part; the former is an inertial sensor module to detect FOG episodes, and the latter is a microvibrator-embedded insole to facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are recruited and conduct FOG-provoking tasks during their medication "OFF" or "late On" state in a laboratory setting. The investigators test if the SSS device could facilitate lateral weight shift and help gait reinitiation, as well as the reliability. The second-year study is to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its effect on FOG, fall, and walking function. The investigators recruit PD patients with FOG, and randomly assign them into the experimental and control groups. Both groups wear the SSS device during the daytime for ten weeks, and the stimulator part is turned on during the first six weeks (intervention phase) only in the experimental group. The stimulator part is then kept off during the last four weeks (follow-up phase) in both groups. The effect of the SSS device is evaluated by the outcomes including FOG severity, fall and walking function, which are measured prior/after the intervention phase and after the follow-up phase.
Clinical relevance: This project tempts to combine real-time gait analysis with somatosensory-induced postural readjustment, and using this novel approach to improve FOG and fall in people with PD. The results of this projects might also provide an objective, long-term assessment tool to measure the FOG phenomenon for clinical and research fields.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without real-time somatosensory cue | No intervention | –Parkinson patients wear the somatosensory stimulation system but not receive the real-time somatosensory cue during freezing-of-gait episodes. |
| With real-time somatosensory cue | Experimental | Device: Real-time somatosensory cueParkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinsonian with Hoehn-Yahr score between 2 to 4
- Suffering freezing-of-gait in the recent week
- Able to walk unassisted over 30 meters in medication OFF period
Key exclusion criteria (5 listed)
- Non-idiopathic Parkinsonian
- Comorbid with uncontrolled neurological, cardiovascular and orthopedic diseases that might affect balance and mobility
- Impaired cognitive function
- Abnormal plantar sensory function
- Abnormal coagulation function
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 |
|---|---|---|
| Real-time somatosensory cueA novel sensory cue proposed in this study, which designed to facilitate weight shift during freezing-of-gait episodes. This sensory cue is controlled by the real-time analysis of gait pattern, and given only when freezing-of-gait detected. | Device | With real-time somatosensory cue |
Primary outcome
Reliability of the somatosensory stimulation system
Time frame: 2 weeks
The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
Validity of the somatosensory stimulation system
Time frame: 2 weeks
If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
Fall prevention
Time frame: 10 weeks
If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
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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.
Ruey-Meei Wu, Professor principal investigator
Department of Neurology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
Kwan-Hwa Lin, Professor principal investigator
Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time somatosensory cue in people with Parkinson Disease, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 3 inclusion and 5 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 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 Ruey-Meei Wu, Professor (886-2-23123456 ext. 2144, robinwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the somatosensory stimulation system (time frame: 2 weeks). The study lists 3 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 23 Oct 2013.