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NCT04919161 · ClinicalTrials.gov registry record · NA
Explorations of the Benefits of the ZeroG TRiP System to Improve Balance in Patients Following Stroke
A NA study, sponsored by Gaylord Hospital.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT04919161: Completed NA study, sponsored by Gaylord Hospital.
NCT04919161 is a NA study that has completed, run by Gaylord Hospital. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04919161, a NA study, has completed, sponsored by Gaylord Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
Strokes are neurological events that can lead to devastating physical and cognitive deficits, such as the inability to ambulate, impaired balance regulation, and loss of coordination. Due to the physical and cognitive deficits experienced following a stroke, many require admission to an inpatient rehabilitation facility to maximize their independence before returning to the home setting. The ability to walk, stand, climb stairs, and other mobility-related functional tasks, are critical components of achieving this functional independence. However, it is often difficult for post-stroke patients with balance impairments to safely practice balance and gait training without putting both therapists and patients at risk for injury. Incorporating robotic technologies to neurological rehabilitation can play a critical role in delivering safe and effective gait and balance therapy. Body-weight support systems (BWSSs) unload paretic lower limbs, patients with gait impairments can practice a higher repetition of steps in a safe, controlled manner. As participants perform gait training, these systems support the participant's body-weight, permitting those with excessive weakness and poor coordination, to ambulate and perform more intensive therapy sessions sooner in their recovery, with minimal risk injurious fall. In addition to BWSSs, balance perturbation systems, which purposefully unbalance participants so to rehabilitate their postural control, have been used to improve gait and balance-control after stroke, or other age and disease related balance impairments. The goal of this study was to evaluate the efficacy of a recently developed, not yet reported, balance perturbation module for the ZeroG BWSS. This new balance perturbation training module is directly integrated into the ZeroG BWSS and allows for the direct induction of safe lateral, anterior, and/or posterior perturbations via a Wi-Fi-enabled handheld device. During both stationary and ambulatory activities, this
Primary Outcome
The Berg Balance Scale is a standardized objective measure of a subject/participant's balance. It is scored on a scale of 0 to 56, with 56 being the best score possible. Admission and discharge Berg scores are collected from a chart review within 48 hours of participant discharge. The change in Berg score is calculated by subtracting the participants admission or pre-assessment score from their discharge or post-assessment score: (Post assessment)-(Pre assessment)
Interventions
- DEVICE Body weight support system control group
- DEVICE Body weight support system with balance perturbations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2020-08-28 |
| Phase | NA |
What the finished NCT04919161 record still lists
NCT04919161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Body weight support system control group is the first listed.
NCT04919161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04919161 about?
NCT04919161 is a clinical study titled "Explorations of the Benefits of the ZeroG TRiP System to Improve Balance in Patients Following Stroke". Strokes are neurological events that can lead to devastating physical and cognitive deficits, such as the inability to ambulate, impaired balance regulation, and loss of coordination. Due to the physical and cognitive deficits experienced following a stroke, many require admission to an inpatient re...
What is the current status of trial NCT04919161?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2019-10-03. Estimated completion is 2020-08-28.
What interventions are being tested in trial NCT04919161?
The interventions under investigation include: Body weight support system control group (DEVICE), Body weight support system with balance perturbations (DEVICE).
Who is sponsoring clinical trial NCT04919161?
This trial is sponsored by Gaylord Hospital, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04919161's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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