NCT06548087

Use Of Gigstride Device In Patients With Lower Extremity Deficit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Ambulation Difficulty
• Lower Extremity Problem

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-08-26
• Completion: 2025-11-06
• First posted: 2024-08-12
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States