Use Of Gigstride Device In Patients With Lower Extremity Deficit

NCT06548087 | Completed

• 1 other identifier: IRB00406374
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ambulation Difficulty; Lower Extremity Problem

Outcome Measures

Primary Outcomes (1)

• Device Feasibility as assessed by ambulatory device aid score

  The investigators will assess the participants comfort and ease of use of the proposed device with a questionnaire that consists of 11 questions in a likert scale. 1 = strongly agree to 5 = strongly disagree. Lowest score of 11 = participant agrees that the device is a feasible option as an ambulatory aid. Highest score of 55 = participants disagree that the proposed device can be used as an ambulatory aid.

  1 year

Study Arms (1)

Use of Gigstride Ambulatory Device

EXPERIMENTAL

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.

Device: Gigstride Ambulatory Device

Interventions

Gigstride Ambulatory Device DEVICE

For patients who are scheduled to be seen by the investigator in clinic with one of the above diagnoses, and recommended to use some type of ambulatory aid, the investigator will offer the Gigstride ambulatory device as an alternative and inquire about the patient's interest in participating in the study. After choosing to be a part of the study, the participant will use Gigstride 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 participant 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.

Use of Gigstride Ambulatory Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age \> 18
• Has undergone treatment for a lower extremity mobility deficit, with one of the following causatives Principal Diagnoses Osteoarthritis hip, knee, spine Pre or post hip replacement Pre or post knee replacement Multiple Sclerosis Mild to moderate central spinal stenosis Foot drop Degenerative changes, not otherwise specified Balance issues
• Recommended cane, brace, walker, Ankle Foot Orthoses, or electronic or robotic device for management
• Provide written consent for participation.
• Ability to wear shoes with laces

You may not qualify if:

• Inability to walk.
• Shoulder operation within 1 year preceding the study date.
• Injury due to a work accident (e.g. workers comp)
• Higher functions do not enable proper comprehension of protocol or reliable data recording.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Gigstride Corporation: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Akhil Chhatre, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: October 8, 2024
• Primary Completion: August 26, 2025
• Study Completion: November 6, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)