Multimodal Haptic Feedback for Plantar Sensory Substitution

Not Applicable

Recruiting

• Conditions: Hypoesthesia

• Registration Number: NCT06232512
• Lead Sponsor: Shirley Ryan AbilityLab

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.

Detailed Description

OBJECTIVES:

1. 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.

2. 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.

3. Investigate whether a haptic device can improve outcomes on motor evaluation tasks.

Study Timeline

• Study Start: 2023-04-20
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pressure data from the insoles	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.

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States