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Clinical Trials/NCT06232512
NCT06232512
Recruiting
N/A

Multimodal Haptic Feedback for Plantar Sensory Substitution

Shirley Ryan AbilityLab1 site in 1 country100 target enrollmentApril 20, 2023
ConditionsHypoesthesia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypoesthesia
Sponsor
Shirley Ryan AbilityLab
Enrollment
100
Locations
1
Primary Endpoint
Pressure data from the insoles
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2023
End Date
December 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pressure data from the insoles

Time Frame: 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.

Study Sites (1)

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