Multimodal Haptic Feedback for Plantar Sensory Substitution

NCT06232512 | Recruiting

• 1 other identifier: STU00218277
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoesthesia

Keywords

Plantar Sensation

Outcome Measures

Primary Outcomes (1)

• Pressure data from the insoles

  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.

  During the intervention

Study Arms (1)

Exploratory Arm

EXPERIMENTAL

Individuals will complete standardized balance and walking tasks with and without sensory substitution from the haptic device system.

Device: Haptic Device

Interventions

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.

Exploratory Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Querrey Simpson Institute for Bioelectronics: collaborator
• Northwestern University: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Hypesthesia

Condition Hierarchy (Ancestors)

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

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shreya Aalla, BS

CONTACT

312-238-7323; saalla@sralab.org

Sara Prokup, DPT

CONTACT

312-238-1255; sprokup@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 30, 2024
• Study Start: April 20, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

US (1)