Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400186
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-26
Brief Title:
Movement Amplification Gait Training to Enhance Walking Balance Post-Stroke
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Movement Amplification Gait Training to Enhance Walking Balance Post-Stroke
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 a leading cause of disability in the United States affecting approximately 795000 people annually The Veterans Health Administration provides over 60000 outpatient visits for stroke-related care annually at a cost of over 250 million Among ambulatory people with chronic stroke PwCS impaired balance is a common health concern that substantially limits mobility those with the worst balance walk the least This project will explore adaptive strategies employed by PwCS in balance challenging environments and if a novel gait training intervention using a robotic device to amplify a persons self-generated movements can improve walking balance The development of effective interventions to increase walking balance among PwCS will positively impact Veterans health quality of life and ability to participate in walking activities
Detailed Description:
Background There is a pressing need to develop effective methods to enhance walking balance in people with chronic stroke PwCS Interventions that amplify self-generated movements may accelerate motor learning by enhancing a persons perception of movement errors This method could potentially be applied to help PwCS improve walking balance To this end the investigators have developed a cable-driven robot to create a Movement Amplification Environment MAE during treadmill walking The MAE challenges walking balance by applying lateral forces to the pelvis that are proportional in magnitude to real-time lateral center of mass COM velocity
Unlike a popular form of balance training that uses unpredictable perturbations to enhance reactive balance training in a MAE targets anticipatory balance by developing predictive control mechanisms that are likely to persist when the training environment is removed after-effects The investigators believe that supplementing high-intensity gait training the recommended practice to improve walking speed and distance with a MAE will substantially enhance walking balance Thus the purpose is to evaluate the unique effects of MAE training on walking balance in PwCS and determine feasibility of conducting high-intensity gait training in a MAE
Specific Aims Aim 1 To evaluate gait patterns PwCS adapt during and immediately following walking practiced in two balance-challenging training environments MAE and unpredictable lateral perturbations Aim 2 To establish feasibility of high intensity gait training in MAE the investigators will evaluate cardiovascular intensity during gait training interventions performed in either a natural unmodified environment or a MAE
Approach Aims 1 15 PwCS will participate in a single-day experiment evaluating gait biomechanics COM dynamics and stepping patterns during and immediately following treadmill walking performed in a MAE or while receiving frequent unpredictable lateral perturbations Outcomes will assess if changes in gait patterns to maintain stability persist immediately following exposure to either of the balance-challenging environments Aim 2 15 PwCS will participate in two high-intensity gait training sessions One session will be performed in a natural unmodified environment the other in a MAE The investigators will quantify differences in mean heart rate HR between the two sessions and whether mean HR is in the target high-intensity range of 70-85 of maximum HR
Impact This project will identify if and how PwCS uniquely adapt locomotor strategies following exposure to balance challenging environments and evaluate feasibility of administering high-intensity gait training in a MAE Training walking balance of PwCS in a MAE by amplifying their own self-generated movements is a radical departure from current practice and could substantially enhance walking balance Successful outcomes will motivate a future randomized controlled trial assessing the efficacy of MAE training to enhance walking balance in PwCS
Unlike a popular form of balance training that uses unpredictable perturbations to enhance reactive balance training in a MAE targets anticipatory balance by developing predictive control mechanisms that are likely to persist when the training environment is removed after-effects The investigators believe that supplementing high-intensity gait training the recommended practice to improve walking speed and distance with a MAE will substantially enhance walking balance Thus the purpose is to evaluate the unique effects of MAE training on walking balance in PwCS and determine feasibility of conducting high-intensity gait training in a MAE
Specific Aims Aim 1 To evaluate gait patterns PwCS adapt during and immediately following walking practiced in two balance-challenging training environments MAE and unpredictable lateral perturbations Aim 2 To establish feasibility of high intensity gait training in MAE the investigators will evaluate cardiovascular intensity during gait training interventions performed in either a natural unmodified environment or a MAE
Approach Aims 1 15 PwCS will participate in a single-day experiment evaluating gait biomechanics COM dynamics and stepping patterns during and immediately following treadmill walking performed in a MAE or while receiving frequent unpredictable lateral perturbations Outcomes will assess if changes in gait patterns to maintain stability persist immediately following exposure to either of the balance-challenging environments Aim 2 15 PwCS will participate in two high-intensity gait training sessions One session will be performed in a natural unmodified environment the other in a MAE The investigators will quantify differences in mean heart rate HR between the two sessions and whether mean HR is in the target high-intensity range of 70-85 of maximum HR
Impact This project will identify if and how PwCS uniquely adapt locomotor strategies following exposure to balance challenging environments and evaluate feasibility of administering high-intensity gait training in a MAE Training walking balance of PwCS in a MAE by amplifying their own self-generated movements is a radical departure from current practice and could substantially enhance walking balance Successful outcomes will motivate a future randomized controlled trial assessing the efficacy of MAE training to enhance walking balance in PwCS
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 |
|---|---|---|---|
| 1I21RX004882 | OTHER_GRANT | Department of Veterans Affairs | None |