Gigstride Device for Difficulty Walking

Overseen By Akhil Chhatre, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Inability to walk, recent shoulder operation, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

20 Participants Needed

Trial Summary

What is the purpose of this trial?

For patients with lower extremity deficits, the investigator(s) would like to assess implementing use of Gigstride ambulatory device to assess the following: * Patient satisfaction with use of ambulatory device * Effects of Gigstride device utilization on kinetics, biomechanics * Effects of Gigstride device utilization on walking speed, stair speed, stability

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 Gigstride Device treatment for difficulty walking?

Research on similar devices, like a biofeedback device for improving heel-to-toe gait in seniors, shows that such devices can effectively classify and improve walking patterns with high accuracy. Additionally, a weight-relieving walker has been shown to significantly aid patients with severe walking difficulties, suggesting that devices designed to assist with walking can be beneficial. ^{1 2 3 4 5}

How is the Gigstride Device treatment different from other treatments for difficulty walking?

The Gigstride Device is unique because it combines real-time gait analysis with biofeedback to help improve walking patterns, unlike traditional physiotherapy which is limited to clinical settings. It uses sensors to detect and classify step quality, providing immediate feedback to the user, which can enhance rehabilitation outside of a clinical environment. ^{2 6 7 8 9}

Research Team

Akhil Chhatre, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over 18 with walking difficulties due to lower limb problems like osteoarthritis, spinal issues, multiple sclerosis, or foot drop. They should be using mobility aids and able to wear laced shoes. Participants must have had treatment for their mobility issue and provide consent.

Inclusion Criteria

I am older than 18.

I have been treated for difficulty moving due to conditions like arthritis or MS.

I have given my written consent to participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Gigstride ambulatory device to perform tasks and complete a questionnaire

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Gigstride Device

Trial Overview The study tests the Gigstride ambulatory device on patients with limited mobility in their legs. It will measure patient satisfaction, changes in walking mechanics, speed on flat surfaces and stairs, as well as overall stability while using the device.

Participant Groups

Group I: Use of Gigstride Ambulatory Device Experimental Treatment 1 Intervention

The participant will be use the Gigstride ambulatory device to perform the following tasks: * Walk a different distances to assess speed and fatigue * Perform functional mobility tasks (sit-to-stand, stand-to sit, stand-pivots, etc.) The participants will then be asked to fill out a questionnaire, "Gigstride Clinical Trial Questionnaire" that will be used for qualitative data, such as ease of use and comfortability with using the device. The overall amount of time for the evaluation and questionnaire will take approximately 30 minutes to 1 hour.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Gigstride Corporation

Collaborator

Trials

1

Recruited

20+

Findings from Research

The Ambulosono wearable sensor system demonstrated high accuracy and reliability in measuring gait parameters, with a mean percentage error of less than 10% compared to true values during tests with 15 participants.

In head-to-head comparisons, the Ambulosono system outperformed the iPod touch sensor system, indicating it could be a cost-effective alternative for use in clinical rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Validation of Ambulosono: A Wearable Sensor for Bio-Feedback Rehabilitation Training. Chomiak, T., Sidhu, AS., Watts, A., et al.[2020]

A new device has been developed to distinguish between healthy heel-to-toe walking and shuffling gait in older adults, providing real-time feedback to improve gait quality.

In a validation study, the device achieved an impressive accuracy of 84.1% in classifying gait types, with high sensitivity (92.4%), indicating it could be a valuable tool for gait rehabilitation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Validation of a Biofeedback Device to Improve Heel-to-Toe Gait in Seniors. Vadnerkar, A., Figueiredo, S., Mayo, NE., et al.[2018]

The SHIMMER wireless sensor platform shows excellent agreement with the established CODA motion analysis system for measuring gait parameters, indicating its reliability for ambulatory monitoring.

With high correlation in stride, swing, and stance times during walking and running trials, the SHIMMER is a promising, cost-effective tool for assessing gait in the aging population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SHIMMER: A new tool for temporal gait analysis. O'Donovan, KJ., Greene, BR., McGrath, D., et al.[2020]

The SmartBoot, a smart offloading device for diabetic foot ulcers, demonstrated high accuracy in monitoring patient adherence with an average accuracy of 89.3%, which is crucial for effective healing.

Participants showed improved balance while using the SmartBoot, suggesting that it provides beneficial somatosensory feedback, and most users found it comfortable and easy to use, indicating its potential for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients. Park, C., Mishra, R., Vigano, D., et al.[2023]

The weight relieving walker (WRW) is a novel device designed to partially relieve body weight during ambulation, which helps patients with severe locomotion problems to walk more effectively.

In a study involving 26 patients, the WRW demonstrated significant benefits in facilitating walking movements and improving step symmetry, indicating its potential as an effective walking aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-propelled weight-relieving walker for gait rehabilitation. Dickstein, R., Smolinski, Z., Pillar, T.[2019]

The treadmill apparatus is designed to evaluate and rehabilitate gait in disabled individuals, featuring a body weight support system and adjustable conditions like speed and slope.

This innovative system allows for visible treadmill walking patterns in patients who may struggle with gait, helping to identify and address factors that limit their adaptability after injury or disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A treadmill apparatus and harness support for evaluation and rehabilitation of gait. Norman, KE., Pepin, A., Ladouceur, M., et al.[2019]

The study developed and tested novel algorithms for detecting initial contact (IC) during walking using footswitch and accelerometer sensors on 12 healthy individuals, finding that the footswitch system was significantly more accurate than the accelerometer system for IC detection.

The footswitch algorithm achieved a mean absolute error of just 2.4 ms, which is about 60% lower than errors reported in previous research, suggesting that while footswitch systems are currently preferable for accuracy, accelerometer systems could be improved for their durability and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time gait event detection using wearable sensors. Hanlon, M., Anderson, R.[2013]

The study found that temporospatial gait parameters measured by a new instrumented treadmill system were significantly different from those measured by a conventional instrumented walkway, indicating that the two systems do not provide interchangeable results.

Despite the statistical differences, the correlation between the two systems was high (ranging from 0.79 to 0.95), suggesting that while they measure gait differently, they can still reflect similar trends in gait analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agreement between temporal and spatial gait parameters from an instrumented walkway and treadmill system at matched walking speed. Wearing, SC., Reed, LF., Urry, SR.[2022]

Healthy adults showed significant changes in gait parameters, such as stride velocity and cadence, when using assistive devices (ADs) compared to walking without them, indicating that ADs can impact mobility performance.

Using a four-wheeled walker improved certain gait metrics like stride velocity and cadence compared to a cane, suggesting that the choice of AD should be made carefully to optimize functional mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of using assistive devices on the components of the modified instrumented timed up and go test in healthy subjects. Abualait, TS., Alnajdi, GK.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Development and Validation of Ambulosono: A Wearable Sensor for Bio-Feedback Rehabilitation Training. [2020]

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

Design and Validation of a Biofeedback Device to Improve Heel-to-Toe Gait in Seniors. [2018]

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

SHIMMER: A new tool for temporal gait analysis. [2020]

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

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Self-propelled weight-relieving walker for gait rehabilitation. [2019]

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

A treadmill apparatus and harness support for evaluation and rehabilitation of gait. [2019]

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

Real-time gait event detection using wearable sensors. [2013]

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

Agreement between temporal and spatial gait parameters from an instrumented walkway and treadmill system at matched walking speed. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effects of using assistive devices on the components of the modified instrumented timed up and go test in healthy subjects. [2022]