Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148343
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2005-09-02
Brief Title:
Functional Electrical Stimulation for Footdrop in Hemiparesis
Sponsor:
MetroHealth Medical Center
Organization:
MetroHealth Medical Center
Study Overview
Official Title:
Functional Electrical Stimulation for Footdrop in Hemiparesis
Status:
COMPLETED
Status Verified Date:
2018-05
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 objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles and the walking ability of stroke survivors
The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke
The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke
Detailed Description:
Hemiplegia is a major consequence of stroke and contributes significantly to the physical disability of stroke survivors Foot-drop or inability to dorsiflex the paretic ankle during the swing phase of gait and ankle instability during stance phase are important gait abnormalities that contribute to reduced mobility among stroke survivors In the United States the standard of care in addressing these deficits is the custom molded ankle-foot-orthosis AFO However evolving data now demonstrate that active repetitive movement training is the principal substrate for facilitating motor relearning after stroke Motor relearning is defined as the reacquisition of motor ability after central nervous system injury Thus while an AFO may assist stroke survivors to ambulate in the short-term it is possible that it also inhibits recovery in the long-term Previous studies have demonstrated that active repetitive movement exercises mediated by neuromuscular electrical stimulation NMES facilitate motor relearning among stroke survivors In particular studies have reported that some chronic stroke survivors treated with a peroneal nerve stimulator for foot-drop experience sufficient recovery that they no longer need the peroneal nerve stimulator or an AFO for community ambulation However there are no blinded randomized clinical trials that rigorously evaluate the motor relearning effects of ambulation training with peroneal nerve stimulators Thus the primary aim of this project is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb motor relearning among chronic stroke survivors The secondary aim is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb mobility disability and overall quality of life A single-blinded randomized clinical trial will be carried out to assess the effects of ambulation training with a peroneal nerve stimulator among chronic stroke survivors compared to ambulation training with conventional standard of care which may include an AFO Subjects will be treated for 12 weeks and followed for a total of another 6 months This project will determine the effectiveness of peroneal nerve stimulation in facilitating motor relearning and improving the mobility and quality of life of stroke survivors This proposed approach is expected to improve patient outcome and challenge the present clinical paradigm of prescribing AFOs for stroke survivors with foot-drop
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD044816 | NIH | None | httpsreporternihgovquickSearchR01HD044816 |