Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329765
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-10-06
Brief Title:
CUped An Approach to Motor Recovery Post-Stroke Not Compensation
Sponsor:
Marquette University
Organization:
Marquette University
Study Overview
Official Title:
CUped An Approach to Motor Recovery Post-Stroke Not Compensation
Status:
RECRUITING
Status Verified Date:
2024-03
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 goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community Few stroke survivors achieve this goal Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke Our team has developed a novel exercise intervention called CUped pronounced cupid like the Roman god to address barriers to recovery and improve walking after stroke CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling This project will examine safety acceptability and tolerance to CUped characterize its therapeutic effects and identify dose-response relationships Results will provide preliminary data for an R01 to support a randomized controlled trial RCT CUped is designed to help stroke survivors recover lower limb movement lost to stroke thereby improving walking It is intended to be used as an adjunct to gait training CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery compels use of the paretic lower limb and targets 3 key movement impairments caused by stroke decreased muscle output from the paretic limb inappropriate paretic muscle timing and abnormal interlimb coordination Exercise is done in sitting which enables high repetition practice Like walking CUped requires continuous reciprocal use of both lower limbs effects are likely to transfer to walking The risk-reward profile of this proposal is ideal for an R21 which is an NIH funding opportunity intended to encourage exploratorydevelopmental research by providing support for the early and conceptual stages of project development CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory The investigators have pilot data suggesting that CUped fulfills its design specifications and this study will be the first to test its therapeutic effects In this Stage 1 rehabilitation trial The investigators will support or quickly refute the hypothesis that CUped is safe acceptable and capable of eliciting a therapeutic response in stroke survivors The investigators will also examine tolerance to CUped and dose-response effects If our hypotheses are supported the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care Future work will investigate physiologic mechanisms underlying the effects of CUped
Detailed Description:
The goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community Few stroke survivors achieve this goal Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke Our team has developed a novel exercise intervention called CUped pronounced cupid like the Roman god to address barriers to recovery and improve walking after stroke CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling This project will examine safety acceptability and tolerance to CUped characterize its therapeutic effects and identify dose-response relationships Results will provide preliminary data for an R01 to support a randomized controlled trial RCT CUped is designed to help stroke survivors recover lower limb movement lost to stroke thereby improving walking It is intended to be used as an adjunct to gait training CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery compels use of the paretic lower limb and targets 3 key movement impairments caused by stroke decreased muscle output from the paretic limb inappropriate paretic muscle timing and abnormal interlimb coordination Exercise is done in sitting which enables high repetition practice Like walking CUped requires continuous reciprocal use of both lower limbs effects are likely to transfer to walking The risk-reward profile of this proposal is ideal for an R21 CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory The investigators have preliminary data suggesting that CUped fulfills its design specifications and this study will be the first to test its therapeutic effects In this Stage 1 rehabilitation trial the investigators will support or quickly refute the hypothesis that CUped is safe acceptable and capable of eliciting a therapeutic response in stroke survivors The investigators will also examine tolerance to CUped and dose-response effects If our hypotheses are supported the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care Future work will investigate physiologic mechanisms underlying the effects of CUped CUped uses a split-crank pedaling apparatus with no mechanical connection between the right and left pedals Participants are asked to pedal with both limbs while maintaining a 180 phase relationship When appropriate phasing is not maintained motors assist the lagging limb and resist the leading limb until the desired phasing is restored CUped can also be configured for unilateral and conventional coupled pedaling Stroke survivors will be asked to participate in 24 exercise sessions with CUped They will be encouraged to perform up to 12 bouts of bilateral uncoupled ie split-crank pedaling with motorized intervention Exercise will continue until all 12 bouts have been completed or the task cannot be sustained Immediately after exercising with CUped participants will perform 1 bout of overground gait training Safety acceptability tolerance and movement ability will be assessed to examine the following specific aims Aim 1 Establish safety acceptability and tolerance to CUped During training the investigators will track adverse events absences and the number of repetitions per session of bilateral uncoupled pedaling repssession If there are no adverse events related to participation the investigators will conclude that CUped is safe If 75 of participants attend 75 of training sessions the investigators will conclude that the intervention is acceptable Repssession will be used to quantify tolerance which is expected to increase across sessions As one measure of exercise dose tolerance will be used to characterize dose-response relations and to develop a training protocol for an RCT Safety acceptability and patient tolerance are preconditions of an RCT and they are imperative for clinical adoption Clinical impact demands safe and effective interventions that are feasible and readily accepted by the target population Aim 2 Characterize therapeutic responses to CUped and their relationship to dose Paretic limb use and interlimb coordination will be assessed before after and at the midpoint of training Measures will be made during walking and pedaling An ideal result would be significant improvement in paretic limb use and interlimb coordination during walking However this outcome relies on task-specific effects in pedaling that transfer to walking Hence improved pedaling performance and decreased use of motorized intervention will be assessed for evidence of intermediate effects Correlation will be used to examine relationships between therapeutic responses and exercise dose Measures with significant correlations will be used to develop a regression model describing dose-response relations and to establish dosing protocols
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?:
None
Is an FDA AA801 Violation?:
None