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临床试验/NCT06548087
NCT06548087已完成不适用

Use Of Gigstride Device In Patients With Lower Extremity Deficit

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Device Feasibility as assessed by ambulatory device aid score

研究概览

简要总结

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

详细描述

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.)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Device Feasibility as assessed by ambulatory device aid score

时间窗: 1 year

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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