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An Upper Extremity Exoskeleton to Target Unwanted Joint Synergies During Repetitive Training in Stroke Survivors

Primary Purpose

Acute Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SA controller
TA controller
SA controller early testing
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Stroke, Exoskeleton, upper extremity, robot, rehabilitation, joint synergy, controller, feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: over the age of 18 years, have a Fugl-Meyer Upper Extremity score of 29-42 for moderately impaired (aim 1) or 0-28 for severely impaired (aim 1 and 2), have body dimensions within the limits of the Harmony system suffered a stroke within the past 1-6 months (aim 1) or 1 week (aim 2) Exclusion Criteria: recurrent stroke, unstable cardiovascular, orthopedic, or neurological conditions, a history of seizure, significant communication deficits, severe upper-limb joint pain or limitations that would restrict their ability to complete the protocols, inadequate cognitive or language function to consent or to participate, and (7) no phone number or stable mailing address.

Sites / Locations

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SA controller

early testing

Arm Description

Synergy assistance controller

up to 5 participants testing the SA controller in one visit

Outcomes

Primary Outcome Measures

Change from Baseline Fugl-Meyer Upper Extremity (FM-UE) at 3 weeks
Clinical measure of upper extremity function Range 0 to 66 - 0 is impaired, 66 is unimpaired
Change from Baseline Action Research Arm Test (ARAT) at 3 weeks
Clinical measure of upper extremity function Range 0 to 57 0 is impaired, 57 is unimpaired

Secondary Outcome Measures

Full Information

First Posted
July 10, 2023
Last Updated
July 28, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05962697
Brief Title
An Upper Extremity Exoskeleton to Target Unwanted Joint Synergies During Repetitive Training in Stroke Survivors
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2024 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke is the leading cause of adult-onset disability, and affects 15,000 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 6,000 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 (repetitions/session). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Stroke, Exoskeleton, upper extremity, robot, rehabilitation, joint synergy, controller, feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SA controller
Arm Type
Experimental
Arm Description
Synergy assistance controller
Arm Title
early testing
Arm Type
Other
Arm Description
up to 5 participants testing the SA controller in one visit
Intervention Type
Other
Intervention Name(s)
SA controller
Other Intervention Name(s)
Synergy assistance
Intervention Description
Novel controller to be tested
Intervention Type
Other
Intervention Name(s)
TA controller
Other Intervention Name(s)
Task assistance
Intervention Description
original controller to be tested
Intervention Type
Other
Intervention Name(s)
SA controller early testing
Other Intervention Name(s)
Synergy assistance early testing
Intervention Description
Novel controller to be tested early testing
Primary Outcome Measure Information:
Title
Change from Baseline Fugl-Meyer Upper Extremity (FM-UE) at 3 weeks
Description
Clinical measure of upper extremity function Range 0 to 66 - 0 is impaired, 66 is unimpaired
Time Frame
3 weeks
Title
Change from Baseline Action Research Arm Test (ARAT) at 3 weeks
Description
Clinical measure of upper extremity function Range 0 to 57 0 is impaired, 57 is unimpaired
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: over the age of 18 years, have a Fugl-Meyer Upper Extremity score of 29-42 for moderately impaired (aim 1) or 0-28 for severely impaired (aim 1 and 2), have body dimensions within the limits of the Harmony system suffered a stroke within the past 1-6 months (aim 1) or 1 week (aim 2) Exclusion Criteria: recurrent stroke, unstable cardiovascular, orthopedic, or neurological conditions, a history of seizure, significant communication deficits, severe upper-limb joint pain or limitations that would restrict their ability to complete the protocols, inadequate cognitive or language function to consent or to participate, and (7) no phone number or stable mailing address.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittney C Muir, PhD
Phone
(206) 277-3261
Email
brittney.muir@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittney C Muir, PhD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1532
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittney C Muir, PhD
Phone
206-277-3261
Email
brittney.muir@va.gov
First Name & Middle Initial & Last Name & Degree
Brittney C Muir, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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An Upper Extremity Exoskeleton to Target Unwanted Joint Synergies During Repetitive Training in Stroke Survivors

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