NCT06168396

Somatosensation Device Trial

Testing of the Somatosensation Device (SD) for Device Effectiveness While Enhancing Feedback in Lower Extremities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to test a new device, called the Somatosensation Device, with people who have either a below knee amputation, or neuropathy (i.e. decreased sensation) in their legs. When people have lost sensation in their feet, it may make walking and balance more difficult. The Somatosensation Device is designed to substitute the loss of feeling in a foot by pressing on nerves on the surface of the leg. It presses on the nerves by using a pneumatic balloon to put pressure on your skin. If people receive this extra sensation feedback, it may help improve their walking and balance.

Conditions

• Amputation
• Neuropathy

Interventions

Type	Name	Description
DEVICE	Somatosensation Device	The somatosensation device will be worn on the lower limb (either the residual limb for an amputee, or limb with decreased sensation for a participant with diabetic neuropathy) while performing outcome measures.
OTHER	Baseline	Participants will perform outcome measures without wearing the somatosensation device.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-04-30
• Completion: 2024-05-01
• First posted: 2023-12-13
• Last updated: 2024-12-04

Locations

1 site across 1 country: United States