Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602544
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preventing Freezing of Gait in Parkinsons Disease Using Soft Robotic Apparel
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XF
Brief Summary:
Freezing-of-gait FoG in Parkinson Disease PD is one of the most vivid and disturbing gait phenomena in neurology Often described by patients as a feeling of feet getting glued to the floor FoG is formally defined as a brief episodic absence or marked reduction of forward progression of the feet despite the intention to walk This debilitating gait phenomena is very common in PD occurring in up to 80 of individuals with severe PD When FoG arrests walking serious consequences can occur such as loss of balance falls injurious events consequent fear of falling and increased hospitalization Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations For the proposed study our goal is to understand how low force mechanical assistance from soft robotic apparel can best mitigate gait decline preceding a freezing episode and subsequent onset of FoG by improving spatial eg stride length and temporal features eg stride time variability of walking We hypothesize that the ongoing gait-preserving effects can essentially minimize the accumulation of motor errors that lead to FoG Importantly the autonomous assistance provided by the wearable robot circumvents the need for cognitive or attentional resources thereby minimizing risks for overloading the cognitive systems -- a known trigger for FoG thus enhancing the repeatability and robustness of FoG-preventing effects
Detailed Description:
Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations Given the breakdown of spatiotemporal gait parameters prior to onset of FoG we aim to understand how the use of mechanical assistance from a soft robotic apparel can best mitigate gait decline preceding a freezing episode and subsequent onset of FoG through a multi-day proof-of-concept study In Aim 1 we will determine the biomechanical mechanisms underpinning the effects of robotic apparel on FoG We posit that robotic apparel will prevent FoG by supporting natural gait biomechanics and reducing motor errors and gait degradation ie increase stride length decrease stride variability known to precede freezing In Aim 2 we will quantify the impact of robotic apparel in preventing FoG in PD under a variety of walking conditions in a series of controlled laboratory-based experiments We hypothesize that robotic apparel will be effective in preventing FoG as evidenced by lower percent time spent freezing and lower FoG severity ratio scores IMU data video annotation during walking and turning resulting in farther walking distances 2-Minute Walk Test compared to unassisted walking repeatable across days of testing Additionally we hypothesize that robotic apparel will be effective in preventing FoG across various walking contexts ie walking in open spaces turning dual-tasking and medication onoff In Aim 3 we will examine proof-of-concept of robotic apparel to prevent FoG in the homecommunity during walking under FoG provoking conditions We hypothesize that robotic apparel will be effective in preventing FoG compared to unassisted walking as evidenced by lower percent time spent freezing and lower FoG severity ratio scores IMU data video annotation during walking in the homecommunity including conditions that trigger FoG eg personalized FoG hotspots
The study will utilize a soft robotic apparel that has previously shown to demonstrate robust gait-preserving benefits and FoG prevention in a single-subject repeated measures case study To examine the effectiveness of the intervention using our robotic apparel this 8-visit study will collect data on amount of time spent freezing spatiotemporal gait measures clinical measures and patient perspectives on the device during different standardized assessments and freeze-provoking activities across multiple environments ie home lab and medication states on relative off with and without the robotic apparel assistance
The study will utilize a soft robotic apparel that has previously shown to demonstrate robust gait-preserving benefits and FoG prevention in a single-subject repeated measures case study To examine the effectiveness of the intervention using our robotic apparel this 8-visit study will collect data on amount of time spent freezing spatiotemporal gait measures clinical measures and patient perspectives on the device during different standardized assessments and freeze-provoking activities across multiple environments ie home lab and medication states on relative off with and without the robotic apparel assistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None