Haptic Device for Numbness

Overseen By Sara Prokup, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Spinal cord injury, Amputation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gadget designed to help people who have lost feeling in their feet due to a movement disorder. The device, called the Haptic Device, includes special insoles that sense foot pressure and send signals to a receiver that vibrates or heats up, mimicking the lost sensation. Participants will perform walking and balancing tasks both with and without the device to assess its effectiveness. This trial might suit those who can walk about 30 feet (10 meters) independently or with assistance and have a movement disorder affecting foot sensation. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this haptic device is safe for individuals with movement disorders?

Research shows that haptic devices, like the one under study, are generally safe. These devices use sensors and vibrations to assist people who have lost feeling in their feet. In other studies, users have well-received similar devices, with most reporting little to no discomfort.

Few negative effects have been linked to these haptic systems. When issues occur, they are usually minor, such as mild skin irritation where the device contacts the skin. Importantly, haptic feedback systems are also used safely in other medical areas, such as for people with prosthetic limbs. This suggests the device in this study is likely safe, though individual experiences can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the haptic device for numbness because it offers a novel way to enhance sensory feedback, which is not addressed by current treatments like physical therapy or medications. Unlike traditional methods that focus on improving muscle strength or managing symptoms without directly addressing sensory loss, the haptic device uses sensory substitution to help individuals regain a sense of touch and improve balance and walking tasks. This innovative approach could provide a new level of independence and quality of life for people who experience numbness, making it a promising development in the field.

What evidence suggests that this haptic device is effective for numbness?

Research has shown that haptic devices can help people improve their balance and walking. In this trial, participants will use a haptic system, which includes a flexible shoe insert with pressure sensors, to complete standardized balance and walking tasks. This device converts foot pressure into vibrations or warmth on another part of the body, which the brain interprets as sensation. Early results from other studies suggest this method can lower the risk of falls and make walking easier. This technology holds promise for those who have lost feeling in their feet, offering a new way to enhance daily movement and safety. ^{1 2 3 4 5}

Who Is on the Research Team?

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for individuals with movement disorders leading to reduced sensation or numbness in the soles of their feet. Participants should be able to walk and have a stable condition, but specific details on age or other health requirements are not provided.

Inclusion Criteria

I can walk 10 meters by myself or with help.

Able and willing to give written consent and comply with study procedures

Exclusion Criteria

Any condition that would prevent the safe completion of study activities, as determined by the Principal Investigator

I have an amputation above my knee.

I am capable of giving written consent and following study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the haptic device to complete standardized balance and walking tasks with and without sensory substitution

4-6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Haptic Device

Trial Overview The study tests a haptic device designed to help people who can't feel their feet properly. It uses pressure sensors in an insole and a receiver that vibrates or heats up, aiming to replace the lost foot sensation.

How Is the Trial Designed?

Group I: Exploratory Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Querrey Simpson Institute for Bioelectronics

Collaborator

Trials

1

Recruited

100+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A new device that provides vibrotactile feedback based on the center of pressure (COP) from a prosthetic foot can help transfemoral amputees regain a sense of proprioception, which is crucial for maintaining balance and stability while walking.

In experiments with 9 able-bodied users of a transfemoral prosthetic leg, the device significantly reduced variability in stride length, step width, and trunk sway, suggesting it improves gait stability during locomotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Haptic Feedback System for Phase-Based Sensory Restoration in Above-Knee Prosthetic Leg Users. Plauche, A., Villarreal, D., Gregg, RD.[2018]

A new method using intraneural stimulation provides real-time position feedback and tactile sensations to transradial amputees, significantly improving their ability to perceive limb position and object characteristics.

Two amputees demonstrated near-natural proprioceptive acuity and high performance in object discrimination tasks, suggesting that combining tactile and position feedback can enhance the functionality of myoelectric prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A closed-loop hand prosthesis with simultaneous intraneural tactile and position feedback. D'Anna, E., Valle, G., Mazzoni, A., et al.[2021]

A new sensory substitution device using deep pressure stimulation on the arm has been developed to provide proprioceptive feedback for individuals with PIEZO2 loss of function, who lack proprioception and light touch sensation.

In a study with participants without sensory impairments, the device significantly improved their ability to control a virtual arm's position, suggesting it could effectively aid those with sensory loss in understanding their body position.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Sensory Substitution for Proprioception via Deep Pressure. Kodali, S., Vuong, BB., Bulea, TC., et al.[2023]

A new haptic feedback system using pneumatic actuators has been developed to provide sensory information to patients with lower-limb prostheses or peripheral neuropathy, showing promise in enhancing their sensory experience.

In tests with six normal subjects, the system demonstrated high accuracy in differentiating inflation patterns and force levels, achieving up to 99% accuracy, indicating its potential effectiveness in improving sensory feedback for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A haptic feedback system for lower-limb prostheses. Fan, RE., Culjat, MO., King, CH., et al.[2008]

The paper reviews various techniques for restoring sensory function in upper limb amputees, focusing on sensory substitution and modality-matched feedback methods.

These methods aim to provide amputees with sensory feedback, each having unique advantages and disadvantages, which can enhance the functionality and user experience of prosthetic devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory feedback in upper limb prosthetics. Antfolk, C., D'Alonzo, M., Rosén, B., et al.[2013]

Haptic sensory substitution technologies can help deaf, blind, and deaf-blind individuals improve their language learning, communication, and navigation skills by converting visual and auditory information into tactile feedback.

There is a need for more user-friendly, affordable, and miniaturized haptic devices that can integrate with personal technology like smartphones to enhance acceptance and usability among sensory-disabled individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haptic-assistive technologies for audition and vision sensory disabilities. Sorgini, F., Caliò, R., Carrozza, MC., et al.[2018]

A single-case study demonstrated that an amputee with a bidirectional prosthesis effectively integrated artificial somatosensory feedback with visual information to estimate object size, suggesting a natural combination of sensory inputs.

The use of intraneural stimulation to provide haptic feedback through the ulnar nerve allowed the patient to perceive vibrations in the phantom hand, indicating that this method can successfully substitute for lost sensory feedback and enhance prosthetic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal integration of intraneural somatosensory feedback with visual information: a single-case study. Risso, G., Valle, G., Iberite, F., et al.[2023]

A tactile vibration feedback device was successfully used to help a 20-year-old transtibial amputee improve his balance and walking function after a car accident.

This case report suggests that such devices could be beneficial for other amputees, highlighting the need for further research into their use in rehabilitation and prosthetic technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tactile vibration feedback system on balance function and walking ability of a unilateral transtibial amputee with a prosthesis: A case report. Wang, SQ., Gao, YQ., Xu, ZH., et al.[2022]

The HapticLink system, developed to provide haptic feedback based on weight distribution in prosthetic feet, shows promise in improving balance and self-awareness for lower-limb amputees, potentially reducing fall risk.

Initial tests with lower-limb prosthetic users demonstrated high accuracy in perceiving directional feedback (average 94.44%), indicating that this system could effectively assist amputees during ambulation without needing complex sensor integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HapticLink: A Force-based Haptic Feedback System for Single and Double Lower-Limb Amputees. Canton Leal, JM., Gyllinsky, JV., Arredondo Zamudio, AA., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06232512?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Hypesthesia%22))))&rank=4

Multimodal Haptic Feedback for Plantar Sensory Substitution | ... Investigate whether a haptic device can improve outcomes on motor evaluation tasks. Official Title. Multimodal Haptic Feedback for Plantar Sensory Substitution.

2. sralab.org sralab.org/research/labs/max-nader-rto/projects/haptic-feedback-plantar-sensory-substitution

Multimodal Haptic Feedback for Plantar Sensory Substitution The purpose of this study is to test the use of a system that can read the pressure pattern on the foot and “map” that pattern to another part ...

3. clinicaltrial.be clinicaltrial.be/en/details/423449?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Multimodal Haptic Feedback for Plantar Sensory Substituti... Haptic Device​​ Provides sensory substitution by mapping pressure from the insole sensor onto a corresponding vibrating and heating patch to be ...

4. sralab.org sralab.org/clinical-trials/multimodal-haptic-feedback-plantar-sensory-substitution

Multimodal Haptic Feedback for Plantar Sensory Substitution The purpose of this study is to test the use of a system that can read the pressure pattern on the foot and “map” that pattern to another part of the body (i.e. ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12467846/

Haptic Feedback Systems for Lower-Limb Prosthetic ... Research on sensory substitution indicates that tactile feedback can lower the risk of falls [24], enhance gait efficiency, and improve walking ...