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CompletedNCT06232512Updated Aug 7, 2026

Multimodal Haptic Feedback for Plantar Sensory Substitution

An interventional study of Haptic Device in Hypoesthesia, sponsored by Shirley Ryan AbilityLab. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2023, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hypoesthesia

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Keywords

  • Plantar Sensation
03

In context

Hypesthesia

47 studies on the registry are indexed under Hypesthesia; 12 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 43 interventional studies indexed under Hypesthesia.

Browse Hypesthesia studies →

Lead sponsor

Shirley Ryan AbilityLab is the lead sponsor of 180 studies on the registry; 44 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Exploratory Arm

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

    Device: Haptic Device

Interventions

  • DeviceHaptic 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.

06

What researchers measure

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.

    Time frame: During the intervention

07

Study locations

1 site
  • Shirley Ryan AbilityLab
    Chicago, Illinois 60611, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06232512
Collaborators
Querrey Simpson Institute for Bioelectronics, Northwestern University
Responsible party
Arun Jayaraman, PT, PhD (Principal Investigator, Shirley Ryan AbilityLab) — Principal investigator
First posted
Jan 30, 2024
Start date
Apr 20, 2023
Primary completion
Jun 23, 2026
Completion
Jun 23, 2026
Last update
Aug 7, 2026

Study contacts

Arun Jayaraman, PT, PhD
principal investigator · Shirley Ryan AbilityLab

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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