Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548087
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Use Of Gigstride Device In Patients With Lower Extremity Deficit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use Of Gigstride Device In Patients With Lower Extremity Deficit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For patients with lower extremity deficits the investigators 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
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 bodys 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 patients 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
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 bodys 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None