Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543758
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study to Verify Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot to Improve Gait in Stroke Patients Investigator Initiated Single Center Single Group Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The goal of this clinical trial is to evaluate the effectiveness and safety of a home-based robotic-assisted gait rehabilitation service using a wearable exoskeletal robot for stroke patients
The main questions it aims to answer are
Can home-based robotic-assisted gait training improve walking speed in stroke patients
Does this intervention enhance body composition gait patterns balance in participants
How satisfied are participants with the use of the wearable exoskeletal robot
Researchers will compare pre- and post-intervention walking speeds body composition spatiotemporal parameters balance and satisfaction survey and does not establish a control group
Participants will
Wear a wearable exoskeletal robot for gait training
Undergo 10 sessions of 30-minute gait training over 4 weeks at home or in nearby indoor spaces
Participate in physical function assessments including the 10-meter walk test Timed Up and Go TUG test and Berg Balance Scale before and after the intervention
Complete quality of life and depression inventories before and after the intervention
The main questions it aims to answer are
Can home-based robotic-assisted gait training improve walking speed in stroke patients
Does this intervention enhance body composition gait patterns balance in participants
How satisfied are participants with the use of the wearable exoskeletal robot
Researchers will compare pre- and post-intervention walking speeds body composition spatiotemporal parameters balance and satisfaction survey and does not establish a control group
Participants will
Wear a wearable exoskeletal robot for gait training
Undergo 10 sessions of 30-minute gait training over 4 weeks at home or in nearby indoor spaces
Participate in physical function assessments including the 10-meter walk test Timed Up and Go TUG test and Berg Balance Scale before and after the intervention
Complete quality of life and depression inventories before and after the intervention
Detailed Description:
After obtaining informed consent a screening test is conducted The screening test includes a review of the participants baseline symptoms and signs medical history and medication usage followed by a physical examination and assessment of gait status including the use of assistive devices and gait patterns Participants who pass the screening test undergo an initial assessment within seven days
The initial assessment includes physical function tests such as the 10-meter walk test the Timed Up and Go TUG test and the Berg Balance Scale along with quality of life and Beck Depression Inventory assessments Participants who complete the initial assessment begin robotic-assisted gait training within two days
The training is conducted using a wearable exoskeletal robot for gait training at home or in nearby indoor spaces The training lasts for four weeks with sessions held 2-3 times per week totaling 10 sessions each lasting 30 minutes
After four weeks the robotic-assisted gait training concludes and within two days an endpoint assessment identical to the initial assessment is performed Satisfaction with the wearable exoskeletal robot is also evaluated
Any device malfunctions are addressed and documented The usage and satisfaction levels of the wearable exoskeletal robot are analyzed and pre- and post-training assessment metrics are compared
The initial assessment includes physical function tests such as the 10-meter walk test the Timed Up and Go TUG test and the Berg Balance Scale along with quality of life and Beck Depression Inventory assessments Participants who complete the initial assessment begin robotic-assisted gait training within two days
The training is conducted using a wearable exoskeletal robot for gait training at home or in nearby indoor spaces The training lasts for four weeks with sessions held 2-3 times per week totaling 10 sessions each lasting 30 minutes
After four weeks the robotic-assisted gait training concludes and within two days an endpoint assessment identical to the initial assessment is performed Satisfaction with the wearable exoskeletal robot is also evaluated
Any device malfunctions are addressed and documented The usage and satisfaction levels of the wearable exoskeletal robot are analyzed and pre- and post-training assessment metrics are compared
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