- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01772186
Freezing of Gait Correction and Fall Prevention: Developing a Real-time Somatosensory Stimulation System
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ruey-Meei Wu, Professor
- Telefoonnummer: 2144 886-2-23123456
- E-mail: robinwu@ntu.edu.tw
Studie Contact Back-up
- Naam: Wen-Chieh Yang, Ph.D. student
- Telefoonnummer: 886-2-33668149
- E-mail: d98428003@ntu.edu.tw
Studie Locaties
-
-
-
Taipei, Taiwan, 100
- Werving
- National Taiwan University Hospital
-
Contact:
- Ruey-Meei Wu, Professor
- Telefoonnummer: 2144 886-2-23123456
- E-mail: robinwu@ntu.edu.tw
-
Contact:
- Wen-Chieh Yang, Ph.D. student
- Telefoonnummer: 886-2-33668149
- E-mail: d98428003@ntu.edu.tw
-
Hoofdonderzoeker:
- Ruey-Meei Wu, Professor
-
Hoofdonderzoeker:
- Kwan-Hwa Lin, Professor
-
Taipei, Taiwan, 100
- Nog niet aan het werven
- National Taiwan University Hospital
-
Contact:
- Ruey-Meei Wu, Professor
- Telefoonnummer: 2144 886-2-23123456
- E-mail: robinwu@ntu.edu.tw
-
Contact:
- Wen-Chieh Yang, Ph.D. student
- Telefoonnummer: 886-2-33668149
- E-mail: d98428003@ntu.edu.tw
-
Hoofdonderzoeker:
- Ruey-Meei Wu, Professor
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Geen tussenkomst: Without real-time somatosensory cue
Parkinson patients wear the somatosensory stimulation system but not receive the real-time somatosensory cue during freezing-of-gait episodes.
|
|
Experimenteel: With real-time somatosensory cue
Parkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Reliability of the somatosensory stimulation system
Tijdsspanne: 2 weeks
|
The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
|
2 weeks
|
Validity of the somatosensory stimulation system
Tijdsspanne: 2 weeks
|
If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
|
2 weeks
|
Fall prevention
Tijdsspanne: 10 weeks
|
If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.
|
10 weeks
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Ruey-Meei Wu, Professor, Department of Neurology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
- Hoofdonderzoeker: Kwan-Hwa Lin, Professor, Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 201112158DIB
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Ziekte van Parkinson
-
Institute for Neurodegenerative DisordersVoltooidParkinson | Parkinson syndroomVerenigde Staten
-
Centre Hospitalier Universitaire DijonWervingIdiopathische ziekte van Parkinson | Parkinson syndroomFrankrijk
-
ProgenaBiomeWervingZiekte van Parkinson | Ziekte van Parkinson met dementie | Parkinson-Dementie Syndroom | Ziekte van Parkinson 2 | Ziekte van Parkinson 3 | Ziekte van Parkinson 4Verenigde Staten
-
Assiut UniversityNog niet aan het wervenMr in Parkinson
-
Hacettepe UniversityVoltooidIdiopathische ziekte van ParkinsonKalkoen
-
UCB PharmaVoltooidIdiopathische ziekte van ParkinsonDuitsland
-
National Heart, Lung, and Blood Institute (NHLBI)VoltooidZiekte van Parkinson 6, vroege aanvang | Ziekte van Parkinson (autosomaal recessief, vroeg begin) 7, Mens | Ziekte van Parkinson Autosomaal Recessief, vroeg begin | Ziekte van Parkinson, Autosomaal Recessief Early-Onset, Digenic, Pink1/Dj1Verenigde Staten
-
National Yang Ming UniversityOnbekendZiekte van Parkinson met vroege aanvang | Ziekte van Parkinson in een vroeg stadium
-
Ahram Canadian UniversityAin Shams UniversityWervingZiekte van Parkinson | Parkinson | De ziekte van Parkinson en parkinsonismeEgypte
-
Institute for Neurodegenerative DisordersUnited States Department of Defense; Molecular NeuroImagingVoltooidZiekte van Parkinson | Parkinson syndroomVerenigde Staten