A combination of smart clothing and an exoskeleton to aid those with mobility issues. The Neural Sleeve uses functional electronic stimulation (FES) to aid walking in those with multiple sclerosis (MS) and similar conditions. In a small clinical trial, it reduced foot drop, which is the inability to dorsiflex, or raise the front part of the foot, due to weakness or paralysis of the muscles in the front of one’s lower leg. This is seen in the gait of those with MS, traumatic brain injury, stroke, spinal cord injury, and cerebral palsy. (This Editor also knew someone for whom leg drop was an initial sign of a brain aneurism.) This disturbed gate dramatically increases fall risk.
The Neural Sleeve works through sensors in the sleeve that monitor movement for muscle firing and limb position, while the analysis, connected to the device through an app, determines the FES to activate the necessary muscles precisely coordinated to the gait cycle. The developer is Cionic, located in the Bay Area of California, still in seed rounds, but marketing to both physicians and direct to consumer.
Of 34 final participants with a mixture of causes in a small clinical trial:
- It improved foot angle in 96% of participants, a 3.4% increase in heel-toe time, and a 5.2% increase in dorsiflexion at heel strike
- Inversion (turning in) of the foot also was reduced by 3.6 degrees on average.
- After eight weeks of use, mobility improved 30% on average.
- In addition, the number of patients reporting moderate to severe pain reduced by 60%, and the number reporting moderate to severe anxiety or depression dropped by 75%.
The clinical trial is in preprint 6 June in Medrxiv as Augmenting gait in a population exhibiting foot drop with adaptive functional electrical stimulation.
The Neural Sleeve received FDA Class II medical device clearance in March. However, it is still in pre-orders, selling out 2022, with 2023 to open later this summer. Multiple Sclerosis News Today, Medium post on foot drop in the Cionic blog, other Medium posts Hat tip to TTA founder Steve Hards