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NCT06602544 · ClinicalTrials.gov registry record · NA
Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease
A NA study of Parkinson Disease (PD), sponsored by Harvard Medical School (HMS and HSDM).
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06602544: Recruiting NA study of Parkinson Disease (PD), sponsored by Harvard Medical School (HMS and HSDM).
NCT06602544 is a NA study of Parkinson Disease (PD) that is actively recruiting participants, run by Harvard Medical School (HMS and HSDM). The registered enrollment target is 20 participants, below the 35-participant average among 3 other Parkinson Disease (PD) trials with a reported enrollment target (43% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06602544, a NA study of Parkinson Disease (PD), is actively recruiting participants, sponsored by Harvard Medical School (HMS and HSDM).
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study 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 (e.g. stride length) and temporal features (e.g. 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.
Primary Outcome
Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.
Conditions Studied
Interventions
- DEVICE Robotic Apparel
Study Locations (2)
Massachusetts
- Harvard Science and Engineering Complex - Allston
- Boston University Sargent College of Health and Rehabilitation Sciences - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-09-03 |
| Est. Completion | 2027-09 |
| Phase | NA |
What NCT06602544 shows while recruiting
NCT06602544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 35-participant average among 3 other Parkinson Disease (PD) trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Parkinson Disease (PD) appearing as the primary indexed condition, and to 1 intervention - of which Robotic Apparel is the first listed.
NCT06602544 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06602544 about?
NCT06602544 is a clinical study titled "Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease". 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...
What is the current status of trial NCT06602544?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-09-03. Estimated completion is 2027-09.
What conditions does trial NCT06602544 study?
This clinical trial studies the following conditions: Parkinson Disease (PD).
What interventions are being tested in trial NCT06602544?
The interventions under investigation include: Robotic Apparel (DEVICE).
Who is sponsoring clinical trial NCT06602544?
This trial is sponsored by Harvard Medical School (HMS and HSDM), which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06602544 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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