NCT03569059Completed
Robot Assisted Virtual Rehabilitation for the Hand Post Stroke (RAVR)
Optimizing Hand Rehabilitation Post Stroke Using Interactive Virtual Environments
Source: ClinicalTrials.gov · Last updated 3 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 115 (actual)
- First submitted
- 10 Apr 2018
- Start date
- 24 Aug 2018
- Primary completion date
- 15 Aug 2024
- Lead sponsor
- New Jersey Institute of Technology
- Diseases
- Stroke
- NCT number
- NCT03569059
What you commit to
- Study type: Interventional
- Participants enrolled: 115
- From 24 Aug 2018 to the primary completion date, 15 Aug 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior stroke with persistent motor impairment or other disabling neurologic condition
Other illness
- non-independent before stroke
- significant illnesses
Other
- receptive aphasia
- hemispatial neglect or severe proprioceptive loss
- severe arthritis that limits arm and hand movements
- a score of ≥1 on the NIHSS limb ataxia item
Who the study is looking for
- unilateral right or left sided stroke within 7 to 30 days of starting study
- sufficient cognitive function to follow instructions
- Fugl-Meyer (FM) of ≤ 49/66
- intact cutaneous sensation (e.g. ability to detect \<4.17 N stimulation using Semmes- Weinstein nylon filaments
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kessler Institute for Rehabilitation Coordinator of this site? Confirm its status | Saddle Brook | United States | Unknown status |
| Kessler Institute for Rehabilitation Coordinator of this site? Confirm its status | West Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.