Use Of Gigstride Device In Patients With Lower Extremity Deficit

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

Study Overview

• Status: Completed
• Conditions: Lower Extremity Problem; Ambulation Difficulty
• Intervention / Treatment: Device: Gigstride Ambulatory Device

Detailed Description

The Gigstride ambulatory device is a novel product that can possibly be used as an alternative ambulatory aid.

• The Gigstride Wearable trainer is a flexible device anchored at distal points in the body. Reciprocating elastic cords follow a path through engineered guides that surround and engage the core, enhance hip and knee flexion, and improve balance. It uses the body's own structure to create symmetry, each step creates momentum and lift, users report feeling lighter, stronger, straighter, and more stable. The gentle, adjustable pressure provides alignment and proprioceptive input that allows for neuromuscular re-education.
• The cords can be configured to target specific therapeutic goals. The two larger diameter cords are used for hip and knee flexion, attaching to the medial and lateral aspect of the shoe at an eyelet near the malleolus. The two smaller diameter cords are used for Foot Drop and attach to the medial and lateral eyelets at the distal part of the shoe, supporting dorsiflexion. In-toeing and out-toeing can be mitigated by attaching both cords either medially or laterally to gently align the foot.
• The Gigstride wearable is a working prototype that can be fitted to almost anyone.

This research is being done to investigate the effectiveness of the Gigstride ambulatory device among individuals who have undergone prior 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. The patient would have to be seen by physical therapy and recommended cane, brace, walker, Ankle Foot Orthoses, or electronic or robotic device for management.

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 patients 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 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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Use of Gigstride Ambulatory Device; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Gigstride Corporation
• Investigators: Principal Investigator: Akhil Chhatre, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Actual): August 26, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mobility Limitation
• Other Study ID Numbers: IRB00406374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, individual results will not be shared. Only the overall results from all participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No