Multimodal Haptic Feedback for Plantar Sensory Substitution

Not Applicable

Recruiting

• Conditions: Hypoesthesia
• Interventions: Device: Haptic Device

• 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

Arm && Interventions

Group	Intervention	Description
Exploratory Arm	Haptic Device	Individuals will complete standardized balance and walking tasks with and without sensory substitution from the haptic device system.

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