Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962697
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-07-10
Brief Title:
An Upper Extremity Exoskeleton to Target Unwanted Joint Synergies During Repetitive Training in Stroke Survivors
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Developing and Determining Feasibility of a Novel Upper Extremity Robotic Exoskeleton to Track and Target Unwanted Joint Synergies During Repetitive Task Training in Stroke Survivors
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Stroke is the leading cause of adult-onset disability and affects 15000 Veterans each year Successful rehabilitation and recovery following a stroke requires therapy including repetitive task training However repetitive task training can be draining for both the clinician and the patient as it requires the participant to complete many repetitions of the same task and those repetitions can be difficult to accomplish with appropriate technique Robot-mediated repetitive task training has the potential to facilitate the clinical delivery of proven rehabilitation programs to Veterans in need and recently a new exoskeleton has been developed called Harmony which can deliver bimanual 3D arm therapy The investigators propose to develop and test two novel controllers synergy avoidance and task assistance that use promising neurological basis for training to facilitate repetitive task training while ensuring correct movement patterns in acute and sub-acute stage stroke patients This has the potential to improve Veterans activities of daily living and quality of life
Detailed Description:
Stroke causes significant long-term disability and the incidence of stroke in Veteran population is high with approximately 6000 VA admissions for acute ischemic stroke per year in 2014 Rehabilitation programs that improve upper extremity function have the potential to impact Veterans activities of daily living and improve their vocation recreation and overall quality of life Repetitive task training RTT is active practice of a task-specific motor activity and is more effective than simple joint movements in improving upper extremity function after treatment However RTT can be draining for both the clinician and the patient as it requires the participant to complete many repetitions of the same task and those repetitions can be difficult to accomplish with appropriate technique Previous research has shown that to significantly affect patient recovery it is critical to initiate RTT in the acute and sub-acute stages maintain health joint coordination and keep the patients engaged and challenged Robot-mediated RTT has the potential to facilitate the clinical delivery of proven rehabilitation programs to Veterans in need and recently a new exoskeleton has been developed called Harmony with the ability to deliver bimanual 3D arm therapy Currently there a lack of tools for delivering RTT in the early stages of recovery while maintaining joint coordination during 3D arm movement and ensuring that assistance commensurate with patient abilities Therefore the objective of this project is to develop novel controllers that use promising neurological basis for training to facilitate repetitive task training while ensuring correct movement patterns in acute and sub-acute stage stroke patients Specifically 1 synergy avoidance SA controller will apply joint torques to push the patients away from the maladaptive joint coordination only interfering with the movements once the subject initiates such a maladaptive movement strategy 2 Task assistance TA controller will apply assistive joint torques to directly help stroke patients achieve 3D RTT activities with correct coordination at a high intensity repetitionssession Aim 1 to develop and determine feasibility of RTT controller H1 SA and TA controllers are feasible as seen by 1 patient safety and 2 abilities of TA and SA controllers to move upper-body joints along task trajectories and away from synergistic coordination respectively Up to five sub-acute stroke survivors will complete RTT activities with both the SA and TA controllers H1 will be considered supported if the applied torque meets the requirements defined by the control law and the feasibility criteria are met for the TA and SA controllers in two consecutive patients Aim 2 determine feasibility of controllers and quantify change in joint coordination during 3-week intervention H2a a 3-week long intervention is feasible with both the controllers as seen by 1 patient safety and 2 abilities for TA and SA controllers to move the upper-body joints toward the desired trajectories for 3D RTT activities while avoiding synergistic compensatory coordination H2b the robotic system will accurately track joint synergies in acute stroke patients before and after a 3-week intervention revealing any change in compensatory strategies Two acute stroke survivors will be recruited Participants will be assigned to either the TA or SA controller and will complete high repetitions of reaching tasks once per day while wearing the Harmony exoskeleton for three weeks Joint kinematic and kinetic data will be recorded by the robotic system in all the sessions Kinematic data will also be recorded in the evaluation sessions before and after the 3-week intervention in two modalities robot in zero-torque mode and using an infrared motion tracking system Joint synergies will be evaluated for the two acute stroke patients before and after a three-week intervention Hypotheses will be considered supported if there is an acceptably low rate of error between the kinematic measurements of the robotic system and the motion capture system New rehabilitation programs that improve upper extremity functional performance have the potential to impact Veterans ADL and improve their vocation recreation and overall quality of life New rehabilitation programs that improve upper extremity function have the potential to impact Veterans ADLs and improve their vocation recreation and overall quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RZ004631 | OTHER_GRANT | Department of Veterans Affairs | None |