Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585943
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
I-Score Intensive Stroke Cycling for Optimal Recovery and Economic Value
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The I-Score Intensive Stroke Cycling for Optimal Recovery and Economic Value Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Traditional rehabilitation approaches are time and personnel intensive and costly and leave 75 of stroke survivors with residual disability We propose a clinical trial to determine effects of forced aerobic exercise FE ie mechanically supplemented in facilitating upper and lower extremity motor recovery post-stroke in an outpatient rehabilitation setting to elucidate neural and biochemical substrates of FE-induced motor recovery and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner thus accelerating its clinical acceptance
Detailed Description:
Traditional rehabilitation approaches following stroke involve 11 motor learning-based training to facilitate recovery of upper extremity UE and lower extremity LE function These time- and personnel-intensive approaches are costly yet leave 75 of stroke survivors with residual disability More effective alternative approaches to facilitate motor recovery following stroke have not been adopted clinically due to excessive time and cost To advance clinical care both effectiveness and cost of a candidate intervention must be considered simultaneously Aerobic exercise AE is known to improve cardiovascular function following stroke and central nervous system CNS function in older adults and neurological populations Strong theoretical arguments suggest that AE may facilitate motor recovery following stroke A protocol that rigorously tests this theory in the subacute stroke population is warranted Animal studies coupled with our preliminary data indicate a specific type of exercise - forced aerobic exercise FE where volitional movements are mechanically supplemented - improves motor recovery following stroke The mechanical assistance provided by FE enables patients to achieve a more rapid and consistent exercise pattern beyond their volitional capabilities while maintaining their aerobic effort within a beneficial range In our initial studies persons completing FE cycling followed by a reduced dose of UE motor task practice exhibited greater recovery of UE motor function compared to those completing unassisted AE and motor task practice or extended sessions of motor task practice alone Animal studies have shown that FE triggers the release of brain-derived neurotrophic factor BDNF and insulin-like growth factor-1 IGF-1 thought to be critical building blocks for neuroplasticity Project Hypothesis FE facilitates high-intensity AE which triggers growth factors essential for neuroplasticity thereby priming the CNS to facilitate motor recovery associated with motor retraining therapies We propose a prospective pragmatic clinical trial to determine effects of FE in facilitating UE and LE motor recovery post-stroke in an outpatient rehabilitation setting to elucidate neural and biochemical substrates of FE-induced motor recovery and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation
Aim 1 Determine effects of FErehab vs time-matched rehab on the recovery of UE motor function
Aim 2 Determine effects of FErehab vs time-matched rehab on recovery of lower extremity motor function
Aim 3 Determine effects of FErehab vs rehab on electrophysiological and biochemical markers of neuroplasticity
Aim 4 Evaluate cost-effectiveness of FErehab vs rehab The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner thus accelerating its clinical acceptance Our mechanistic aim will elucidate the effects of each approach on substrates underlying neuroplasticity
Aim 1 Determine effects of FErehab vs time-matched rehab on the recovery of UE motor function
Aim 2 Determine effects of FErehab vs time-matched rehab on recovery of lower extremity motor function
Aim 3 Determine effects of FErehab vs rehab on electrophysiological and biochemical markers of neuroplasticity
Aim 4 Evaluate cost-effectiveness of FErehab vs rehab The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner thus accelerating its clinical acceptance Our mechanistic aim will elucidate the effects of each approach on substrates underlying neuroplasticity
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