Robotic Exoskeleton Assisted Gait Post Stroke
This study is looking at whether using a robotic exoskeleton device, called EksoGT™, can help people who have recently had a stroke improve their walking. It will compare the walking abilities of people who use the EksoGT™ as part of their rehabilitation to those who receive standard physical therapy. The study also aims to understand how walking with the EksoGT™ affects brain activity. You might be able to join if you are between 21 and 80 years old, had a stroke less than 4 weeks ago, and have weakness on one side of your body. The researchers will measure your functional independence and brain activity to see if the EksoGT™ helps. The study plans to enroll 75 participants, but its current status is unclear.
- Study design
- This interventional study plans to enroll 75 participants. It compares the EksoGT™ device to standard care and a group that only undergoes testing.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in functional independence and brain activity at 10 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Robotic Exoskeleton Assisted Gait Post Stroke
At a glance
Conditions
NCT04309305
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Kessler Foundation
West Orange, New Jerseyno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Karen J. Nolan, PhD · PRINCIPAL_INVESTIGATOR · Kessler Foundation
- Soha Saleh, PhD · PRINCIPAL_INVESTIGATOR · Kessler Foundation
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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What this trial measures
- Functional Independence Measure (FIM) (aim 1)Change from Baseline FIM at 10 weeks
a conventional assessment measure of motor function
- Within-brain functional connectivity (aim 2)Change from Baseline Within-brain functional connectivity at 10 weeks
fMRI connectivity between selected regions of interest within the sensorimotor and attention networks.
- TMS recruitment curve slope (aim 3)Change from Baseline TMS recruitment curve slope at 10 weeks
A recruitment curve created using measure of primary motor cortex Motor Evoked Potential (MEP) at several stimulation thresholds.
- electroencephalogram (EEG) (aim 3)Change from Baseline EEG at 10 weeks
a measure of brain activation at different phases of gait cycle (swing versus double support).
- electromyography (EMG) (aim 3)Change from Baseline EMG at 10 weeks
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
- 10MWT (aims 1-3)Change from Baseline 10MWT at 10 weeks
10 meters walking test to evaluate walking speedafter stroke and in response to the intervention.
- 6MWT (aims 1-3)Change from Baseline 6MWT at 10 weeks
6 minutes walking test to evaluate endurancein connectivity after stroke and in response to the intervention.
- TUG (aims 1-3)Change from Baseline TUG at 10 weeks
time up and go (TUG) test
- structural connectivity (aim 2)Change from Baseline structural connectivity at 10 weeks
Diffusion Tensor Imaging (DTI) and fractal dimensions (FD) measures of structural connectivity