Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04250688
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-07
First Post:
2020-01-28
Brief Title:
Robotic Exoskeleton With Functional Electrical Stimulation in Acute Spinal Cord Injury
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Effect of a Robotic Exoskeleton With Functional Electrical Stimulation on Neural Recovery in Individuals With Acute Spinal Cord Injury
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation FES in persons affected by spinal cord injury designated AIS classification A B C or D Traditionally a person with an American Spinal Injury Association Impairment Scale AIS A injury walking training is not performed Even with AIS B C and D injuries although walking training may be appropriate a person may not walk as much as needed to see an improvement due to environmental and staff limitations The Ekso is a tool to give walking training to patients The investigators aim to see if utilizing these technologies will affect recovery specifically in sensation and muscle activity below the level of the injury as well as the ability to walk
The Ekso is a wearable battery- operated exoskeleton that assists with walking The Ekso has motors at the hip and knee joints to provide assistance that may be needed with walking All motion is initiated either through body weight shifts or the use of an external controller The Ekso robotic exoskeleton has been approved by the Food and Drug Administration as a powered exercise device for rehabilitative purposes such as this study Currently the Ekso is approved for people with spinal cord injuries from T4-L5 given bilateral arm strength of 45 With injuries from C7-T3 individuals must have AIS classification of D with bilateral arm strength of 45 For this study it is possible that Ekso GT will be used outside of the current FDA approval if the injury level is C7-T3 and the person is classified as an AIS A B or C injury level Functional electrical stimulation FES will be used in conjunction with the robotic exoskeleton FES involves using surface electrodes placed on the skin like a sticker over key leg muscles that will be stimulated in the normal walking pattern as a person walks in the device
The Ekso is a wearable battery- operated exoskeleton that assists with walking The Ekso has motors at the hip and knee joints to provide assistance that may be needed with walking All motion is initiated either through body weight shifts or the use of an external controller The Ekso robotic exoskeleton has been approved by the Food and Drug Administration as a powered exercise device for rehabilitative purposes such as this study Currently the Ekso is approved for people with spinal cord injuries from T4-L5 given bilateral arm strength of 45 With injuries from C7-T3 individuals must have AIS classification of D with bilateral arm strength of 45 For this study it is possible that Ekso GT will be used outside of the current FDA approval if the injury level is C7-T3 and the person is classified as an AIS A B or C injury level Functional electrical stimulation FES will be used in conjunction with the robotic exoskeleton FES involves using surface electrodes placed on the skin like a sticker over key leg muscles that will be stimulated in the normal walking pattern as a person walks in the device
Detailed Description:
The purpose of this study is to examine the effectiveness of mobility training using the Ekso robotic exoskeleton with functional electrical stimulation FES on neural recovery in individuals with acute spinal cord injury with American Spinal Injury Association Impairment Scale AIS neurologic classification A B C or D
Specifically individuals with acute SCI in the inpatient rehabilitation setting improve their AIS score after mobility training with the Ekso-FES compared to a control intervention period
In addition the investigators will analyze the influence of training performed early or later in acute rehabilitation phase on muscle properties neural recovery and function
This is an investigational clinical study trialing the efficacy of the Ekso device with FES in the acute SCI population Participants with a diagnosis of spinal cord injury classified as AIS A B C or D will be included Up to ten participants will be recruited to participate in this study This number was arbitrarily chosen as this is an investigational study and there is no previous data on the Ekso device to specifically select subject number based on a power analysis Participants will be recruited from inpatient units at The Shirley Ryan AbilityLab Following screening all subjects will be required to receive medical clearance from their attending inpatient physician
Subjects will be randomized to which order they receive the Ekso intervention A and control B period A then B or B then A The device will be used in the lab and there will be no charge associated with use of the Ekso device
All participants involved in the investigational studytraining will be screened according to general inclusionexclusion criteria after obtaining informed consent and before using the Ekso device
Screening will include
Range of Motion ROM Range of motion of the joints of the upper and lower extremities will be measured using a goniometer
Muscle strength testing upper and lower extremity manual muscle testing to determine qualification for study inclusion
Modified Ashworth Scale MAS The Modified Ashworth Scale is a 6 point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity Tone is scored by passively moving the individuals limb and assessing the amount of resistance to movement felt by the examiner
Upper and lower leg length and hip measurements will be performed to determine safe fit in the exoskeleton device
Specifically individuals with acute SCI in the inpatient rehabilitation setting improve their AIS score after mobility training with the Ekso-FES compared to a control intervention period
In addition the investigators will analyze the influence of training performed early or later in acute rehabilitation phase on muscle properties neural recovery and function
This is an investigational clinical study trialing the efficacy of the Ekso device with FES in the acute SCI population Participants with a diagnosis of spinal cord injury classified as AIS A B C or D will be included Up to ten participants will be recruited to participate in this study This number was arbitrarily chosen as this is an investigational study and there is no previous data on the Ekso device to specifically select subject number based on a power analysis Participants will be recruited from inpatient units at The Shirley Ryan AbilityLab Following screening all subjects will be required to receive medical clearance from their attending inpatient physician
Subjects will be randomized to which order they receive the Ekso intervention A and control B period A then B or B then A The device will be used in the lab and there will be no charge associated with use of the Ekso device
All participants involved in the investigational studytraining will be screened according to general inclusionexclusion criteria after obtaining informed consent and before using the Ekso device
Screening will include
Range of Motion ROM Range of motion of the joints of the upper and lower extremities will be measured using a goniometer
Muscle strength testing upper and lower extremity manual muscle testing to determine qualification for study inclusion
Modified Ashworth Scale MAS The Modified Ashworth Scale is a 6 point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity Tone is scored by passively moving the individuals limb and assessing the amount of resistance to movement felt by the examiner
Upper and lower leg length and hip measurements will be performed to determine safe fit in the exoskeleton device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None