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Completed

NCT Number: NCT06168396

Somatosensation Device Trial

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.

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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Baseline

Other

Participants will perform outcome measures without wearing the somatosensation device.

Primary outcomes

  1. Functional Gait Assessment (FGA)

    Time frame: Baseline, during the intervention

    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.

Secondary outcomes

  1. 10 Meter Walk Test

    Time frame: Baseline, during the intervention

    The 10MWT assesses walking speed in meters per second. In the 10MWT, subjects are directed to walk at their self-selected and maximum safe speed with the effects of acceleration and deceleration minimized (by adding 2 meters at the beginning and at the end of the course to isolate the subject's steady state speed). Any assistive device and orthotic should be kept consistent and documented. Participants will complete three trials at their self-selected speed and three trials at their fast but still safe speed. This will be performed over the GAITRite electronic walkway, to measure temporal-spatial gait parameters.

  2. Mini-BESTest

    Time frame: Baseline, during the intervention

    A multi-task balance assessment that identifies postural control problems across a wide variety of situations.

  3. Activities Specific Balance Confidence Scale (ABC)

    Time frame: Baseline, during the intervention

    A self-reported questionnaire that measures a participant's confidence in their balance in performing various activities without falling or becoming unsteady. Scores are on a 0-100% confidence scale, with higher scores equaling greater confidence.

  4. Vestibular Disorders Activities of Daily Living Scale (VADL)

    Time frame: Baseline, during the intervention

    A self-reported questionnaire that evaluates the effects of vertigo and balance disorders on independence routine activities of daily living. Scores range from 1-8, with lower scores indicating greater independence with activities.

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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