Somatosensation Device Trial

NCT06168396 | Completed

• 1 other identifier: STU00219855
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Functional Gait Assessment (FGA)

  The Functional Gait Assessment is a test to assess an individual's postural stability and ability to perform multiple motor tasks while walking. Tests include walking at different speeds, walking with head turns, turns, stepping over obstacles, walking tandem, walking with eyes closed, walking backwards, and stair navigation. Scores are on a 0-30 scale, with higher scores showing better balance and mobility.

  Baseline, during the intervention

Secondary Outcomes (4)

• 10 Meter Walk Test

  Baseline, during the intervention

• Mini-BESTest

  Baseline, during the intervention

• Activities Specific Balance Confidence Scale (ABC)

  Baseline, during the intervention

• Vestibular Disorders Activities of Daily Living Scale (VADL)

  Baseline, during the intervention

Study Arms (2)

Baseline (Without Somatosensation Device)

ACTIVE COMPARATOR

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

Other: Baseline

With Somatosensation Device

EXPERIMENTAL

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

Device: Somatosensation Device

Interventions

Somatosensation Device 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.

With Somatosensation Device

Baseline OTHER

Participants will perform outcome measures without wearing the somatosensation device.

Baseline (Without Somatosensation Device)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

BaseLine dental cement

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 13, 2023
• Study Start: March 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 1, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

US (1)