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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the Gigstride device, a mobility aid, for individuals with walking difficulties due to lower body issues such as hip or knee problems. The researchers aim to determine if the device improves walking speed, balance, and overall satisfaction during daily activities. Participants will use the device for tasks like standing up and walking, then share their experiences. This trial may suit those who have had hip or knee replacements, osteoarthritis, or similar conditions and are advised to use mobility aids like canes or braces. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance mobility aid options for many.

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 the Gigstride Device is safe for patients with lower extremity deficits?

Research has shown that the Gigstride Device was used safely in previous studies. These studies involved individuals with walking difficulties and found that the device was generally well-tolerated. Participants did not report any serious side effects, indicating no major problems occurred. The research primarily focused on the device's impact on walking and balance, rather than negative reactions. Although the FDA has not yet approved the Gigstride Device for any condition, its use in trials so far suggests it is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Gigstride Device is unique because it aims to enhance mobility through a wearable, user-friendly design, which could help people who have difficulty walking. Unlike traditional physical therapy or assistive devices that often require significant effort and adaptation, the Gigstride Device is designed to be intuitive and easy to use. Researchers are excited about its potential to improve walking speed and reduce fatigue, offering a more efficient way to perform daily tasks like standing and pivoting. This could make a significant difference in the quality of life for users who struggle with mobility issues.

What evidence suggests that the Gigstride device is effective for improving walking difficulties?

Studies have shown that walking programs using wearable devices can effectively improve walking speed, especially in older adults. In this trial, participants will use the Gigstride Device, which uniquely combines real-time walking analysis with feedback to improve walking patterns. Unlike traditional walkers, this device enhances stability and walking speed by providing immediate feedback. Research indicates that devices like Gigstride can lead to better movement control and increased confidence in walking. These features suggest that the Gigstride Device could be a promising tool for those who have difficulty walking due to leg or foot problems. ^{1 2 6 7 8}

Who Is on the Research Team?

Akhil Chhatre, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 given my written consent to participate.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06548087

Use Of Gigstride Device In Patients With Lower Extremity ... This research is being done to investigate the effectiveness of the Gigstride ambulatory device among individuals who have undergone prior ...

2. withpower.com withpower.com/trial/phase-lower-extremity-problem-8-2024-c0617

Gigstride Device for Difficulty Walking The Gigstride Device is unique because it combines real-time gait analysis with biofeedback to help improve walking patterns, unlike traditional ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11406625/

Impact of Wearable Device-Based Walking Programs on Gait ... Our findings display that wearable device-based walking programs are effective in improving gait speed amongst older adults, mainly in those ...

4. researchgate.net researchgate.net/publication/10779452_Ambulatory_Devices_for_Chronic_Gait_Disorders_in_the_Elderly

Ambulatory Devices for Chronic Gait Disorders in the Elderly Walkers can be challenging to handle, however, and can result in poor back balance and decreased arm swing [24, 26, 27]. Walkers need more care ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8059183/

Utilization of wearable technology to assess gait and ... Accelerometers, activity monitors, and pressure sensors were the most commonly used wearable technologies to assess gait and mobility post-stroke.

6. clinconnect.io clinconnect.io/trials/NCT06548087

Use Of Gigstride Device In Patients With Lower Extremity The researchers want to see how satisfied patients are with using this device and how it affects their ability to walk, climb stairs, and maintain stability.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8111581/

Effects of using assistive devices on the components ... This study aimed to investigate the spatiotemporal gait and functional mobility parameters in healthy adults when walking using different ADs.

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/43/NCT07147543/Prot_SAP_000.pdf

Study protocol and Statistical Analysis Plan Official Title of ... device in patients with gait disorders by assessing changes in gait parameters upon wearing the device, thereby exploring its clinical ...