Somatosensation Device Trial

Shirley Ryan AbilityLab

Status: Completed

Conditions: Amputation; Neuropathy

Treatments: Other: Baseline; Device: Somatosensation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06168396

STU00219855

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a below-knee amputation (either unilateral or bilateral) or neuropathy in their lower limbs.
• Ability to wear the somatosensation device on their lower limbs
• Ability to wear test equipment and heart rate monitors.
• Ability to follow simple directions.

Exclusion criteria

• History of severe back pain in the last 3 months.
• History of severe knee pain in the last 3 months.
• Unable to walk for 3 minutes with or without an assistive device
• Poor skin integrity (i.e open wounds, skin breakdown) that could be made worse by wearing the somatosensation device.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Baseline (Without Somatosensation Device)

Active Comparator group

Description:

Participants will perform all outcome measures without wearing the somatosensation device.

Treatment:

Other: Baseline

With Somatosensation Device

Experimental group

Description:

Participants will perform all outcome measures while wearing the somatosensation device.

Treatment:

Device: Somatosensation Device