Multimodal Haptic Feedback for Plantar Sensory Substitution

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Shirley Ryan AbilityLab

Status

Enrolling

Conditions

Hypoesthesia

Treatments

Device: Haptic Device

Study type

Interventional

Funder types

Other

Identifiers

NCT06232512
STU00218277

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Exploratory Arm
Experimental group
Description:
Individuals will complete standardized balance and walking tasks with and without sensory substitution from the haptic device system.
Treatment:
Device: Haptic Device

Trial contacts and locations

1

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Central trial contact

Shreya Aalla, BS; Sara Prokup, DPT

Data sourced from clinicaltrials.gov

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