Randomized Controlled Trial on Robotic Exoskeleton in Spinal Cord Injury: Clinical Outcomes and Cortical Plasticity
About this trial
This trial is enrolling individuals with chronic incomplete spinal cord injuries to test the effect of gait (walking) training with a robotic exoskeleton. Walking training with the exoskeleton (EKSO-GT) will be accompanied by standard locomotor rehabilitation (treadmill stepping). In addition to potential improvements in walking, the trial will use techniques including MRI imaging and EEG signaling during sleep to measure changes in the brain as a result of the training. Researchers want to know if exoskeleton training causes the brain or spinal cord to initiate an adaptive or remodeling response. There are two groups in the study. If selected for the trial, participants will either receive 1) standard locomotor training 2.5 hours per day, 5 days per week over 8 weeks; or 2) the same amount of locomotor training plus 30-40 minute sessions of exoskeleton training, 3 times per week during the first 4 weeks.
Included participants
Traumatic
Non-traumatic
What’s involved
Type
Details
8-week study period: Standard neurorehabilitation walking training, 5 times per week, twice a day, for a total of about 2.5 hours per day. If assigned to the experimental arms using the robotic exoskeleton: Additional training sessions during the first 4 consecutive weeks of the study period. Each rehabilitation session with EKSO-GT will last (operating time) 30-40 minutes. Such training will be carried out for 3 sessions per week.
Potential benefits
Main benefits
Standing/walking/mobility
Additional benefits
General health
Spasticity
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Unknown
- Trial start date
- 10 Dec 2020
- Organisation
- Azienda Usl di Bologna
- Trial recruitment status
- Unknown
- Trial start date
- 10 Dec 2020
- Organisation
- Azienda Usl di Bologna
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more