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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06602544
The ClinicalTrials.gov registry entry for NCT06602544 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 35-participant average among 3 other Parkinson Disease (PD) trials with a reported enrollment target (43% lower). The listed sponsor is Harvard Medical School (HMS and HSDM), which has 26 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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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