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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Haptic Device, Multimodal Haptic Feedback Device, Plantar Sensory Substitution Device for numbness?

Research on similar haptic feedback systems for lower-limb prostheses shows that these devices can improve balance and stability by providing sensory feedback, as seen in studies where users demonstrated improved gait stability and reduced variability in stride length and step width. Additionally, haptic feedback systems have been effective in helping users perceive directional stimuli and force levels accurately, suggesting potential benefits for addressing numbness. ^{1 2 3 4 5}

Is the Haptic Device for Numbness safe for humans?

Research on similar haptic devices, like HapticLink and sensory substitution systems, shows they are generally safe for humans. Participants in studies reported comfort with the feedback intensity, and no significant safety issues were noted. ^{2 4 6 7 8}

How is the Haptic Device treatment for numbness different from other treatments?

The Haptic Device for numbness is unique because it uses sensory substitution, translating force information from the foot into tactile feedback on the thigh, which helps users perceive sensations they otherwise cannot feel. This approach is different from traditional treatments as it provides a novel way to restore sensory feedback through haptic technology, which is not commonly used for numbness. ^{1 3 4 7 9}

Research Team

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Sensory feedback in upper limb prosthetics. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

HapticLink: A Force-based Haptic Feedback System for Single and Double Lower-Limb Amputees. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A haptic feedback system for lower-limb prostheses. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Wearable Sensory Substitution for Proprioception via Deep Pressure. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Haptic Feedback System for Phase-Based Sensory Restoration in Above-Knee Prosthetic Leg Users. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A closed-loop hand prosthesis with simultaneous intraneural tactile and position feedback. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Haptic-assistive technologies for audition and vision sensory disabilities. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Optimal integration of intraneural somatosensory feedback with visual information: a single-case study. [2023]

9. United States 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. [2022]