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NCT03569059 · ClinicalTrials.gov registry record · NA
Robot Assisted Virtual Rehabilitation for the Hand Post Stroke (RAVR)
A NA study of Stroke, Acute, sponsored by New Jersey Institute of Technology.
- Completed
- Registry status
- NA
- Development phase
- 115
- Enrollment target
- 2
- Study locations
NCT03569059: Completed NA study of Stroke, Acute, sponsored by New Jersey Institute of Technology.
NCT03569059 is a NA study of Stroke, Acute that has completed, run by New Jersey Institute of Technology. The registered enrollment target is 115 participants, below the 626-participant average among 25 other Stroke, Acute trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03569059, a NA study of Stroke, Acute, has completed, sponsored by New Jersey Institute of Technology.
- COMPLETED
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study investigates the effects of intensive, high dosage task and impairment based training of the hemiparetic hand, using haptic robots integrated with complex gaming and virtual reality simulations. There is a time-limited period of post-ischemic heightened neuronal plasticity during which intensive training may optimally affect the recovery of motor skills, indicating that the timing of rehabilitation is as important as the dosing. However, recent literature indicates a controversy regarding both the value of intensive, high dosage as well as the optimal timing for therapy in the first two months after stroke. This study is designed to empirically investigate this controversy. It is evident that providing additional, intensive therapy during the acute rehabilitation stay is more complicated to implement and difficult for patients to tolerate, than initiating it in the outpatient setting, immediately after discharge. The robotic/VR system is specifically designed to deliver hand and arm training when motion and strength are limited, using adaptive algorithms to drive individual finger movement, gain adaptation and workspace modification to increase finger and arm range of motion, and haptic and visual feedback from mirrored movements to reinforce motor networks in the lesioned hemisphere.
Primary Outcome
The ARAT assesses upper extremity activity. It is a 19 item test divided into four subscales: grasp, grip, pinch and movement. Scores range from 0-57 with higher scores indicating better performance.
Conditions Studied
Interventions
- DEVICE Early Robotic/VR Therapy (EVR)
- BEHAVIORAL Dose-Matched Usual Physical Therapy Care
- DEVICE Delayed Robotic/VR Therapy (DVR)
Study Locations (2)
New Jersey
- Kessler Institute for Rehabilitation - Saddle Brook
- Kessler Institute for Rehabilitation - West Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2018-08-24 |
| Est. Completion | 2024-08-15 |
| Phase | NA |
What the finished NCT03569059 record still lists
NCT03569059 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 626-participant average among 25 other Stroke, Acute trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Stroke, Acute appearing as the primary indexed condition, and to 3 interventions - of which Early Robotic/VR Therapy (EVR) is the first listed.
NCT03569059 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT03569059 about?
NCT03569059 is a clinical study titled "Robot Assisted Virtual Rehabilitation for the Hand Post Stroke (RAVR)". This study investigates the effects of intensive, high dosage task and impairment based training of the hemiparetic hand, using haptic robots integrated with complex gaming and virtual reality simulations. There is a time-limited period of post-ischemic heightened neuronal plasticity during which in...
What is the current status of trial NCT03569059?
This trial is currently completed. It is a NA study. The enrollment target is 115 participants. The study started on 2018-08-24. Estimated completion is 2024-08-15.
What conditions does trial NCT03569059 study?
This clinical trial studies the following conditions: Stroke, Acute.
What interventions are being tested in trial NCT03569059?
The interventions under investigation include: Early Robotic/VR Therapy (EVR) (DEVICE), Dose-Matched Usual Physical Therapy Care (BEHAVIORAL), Delayed Robotic/VR Therapy (DVR) (DEVICE).
Who is sponsoring clinical trial NCT03569059?
This trial is sponsored by New Jersey Institute of Technology, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03569059 being conducted?
This trial has 2 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke, Acute
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03569059's enrollment target sits among peer trials
115 15th of 25 higher than 11 of 25 other Stroke, Acute trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke, Acute 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.
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