Clinical trial NCT06548087: Use Of Gigstride Device In Patients With Lower Extremity Deficit
Official title: Use Of Gigstride Device In Patients With Lower Extremity Deficit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ambulation Difficulty
Lower Extremity Problem
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Gigstride Corporation
First posted: 2024-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Device Feasibility as assessed by ambulatory device aid score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Akhil Chhatre, MD
role: PRINCIPAL_INVESTIGATOR
References: