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Recruiting

NCT Number: NCT06232512

Multimodal Haptic Feedback for Plantar Sensory Substitution

The study will explore the use of a haptic device for sensory substitution in individuals with a movement disorder that has caused loss of plantar sensation. The haptic device consists of two components. The first element is a flexible insole with embedded pressure-sensing elements that transmit the spatial patterns of applied foot pressure over time. The second element is a haptic receiver with embedded actuators that vibrate or heat up in proportion to the transmitted pressure patterns, thus substituting the patient's lost plantar sensation.

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Key information

Conditions

Hypoesthesia Hypesthesia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Shreya Aalla, BS

CONTACT

[email protected]

312-238-7323

About this study

OBJECTIVES:

  • Identify a systematic, methodical approach to determine whether different users of our haptic device can perceive and use vibrational and thermal feedback in order to correct their posture in real-time.
  • Evaluate whether a haptic device can be used to guide users to maintain a prescribed pattern of pressure on their feet during standing and walking.
  • Investigate whether a haptic device can improve outcomes on motor evaluation tasks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able to ambulate 10 meters with or without assistance
  • Able and willing to give written consent and comply with study procedures

Exclusion criteria

  • Unable to give written consent or comply with study procedures
  • Unable to perceive unsafe levels of heat in relevant areas
  • Has a motor complete spinal cord injury
  • Have transfemoral (above knee) amputation
  • Any condition that would prevent the safe completion of study activities, as determined by the Principal Investigator

Treatment and study plan

Haptic device

Device

Provides sensory substitution by mapping pressure from the insole sensor onto a corresponding vibrating and heating patch to be worn where more sensation is present.

Primary outcomes

  1. Pressure data from the insoles

    Time frame: During the intervention

    The primary outcome is to use the pressure-sensitive insole to ensure that we can accurately record spatial and temporal pressure data from a wide variety of healthy and non-healthy individuals.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Prokup, DPT

CONTACT

[email protected]

312-238-1255

Shreya Aalla, BS

CONTACT

[email protected]

312-238-7323

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Northwestern University
  • Querrey Simpson Institute for Bioelectronics

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Apr 20, 2025

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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