Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619262
Status:
TERMINATED
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Concomitant Application of TENS and NMES on Chronic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Concomitant Application of TENS and NMES on Chronic Stroke Patients A Prospective Randomized Controlled Study
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After the G power analysis it was determined that a total of 60 patients needed initial 1st month and 4th month follow-ups The study was terminated when the follow-ups of 60 patients were completed prospectively
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENS NMES
Brief Summary:
Stroke is a cerebrovascular disorder that can lead to permanent disability and a decline in quality of life Chronic stroke patients often experience decreased balance control which negatively affects activities of daily living and their ability to walk independently Studies conducted with electrical stimulation have shown that it is safe to use on humans Today it is frequently preferred in treatment
Electrical stimulation are effective for treatment of stroke Electrical stimulation has been used as transcutaneous nerve stimulation TENS and neuromuscular electrical stimulation NMES Both of them are effective but not sufficient The concomitant application of TENS and NMES may achieve better results than individually application
Electrical stimulation are effective for treatment of stroke Electrical stimulation has been used as transcutaneous nerve stimulation TENS and neuromuscular electrical stimulation NMES Both of them are effective but not sufficient The concomitant application of TENS and NMES may achieve better results than individually application
Detailed Description:
Stroke is a cerebrovascular disorder that can lead to permanent disability and a decline in quality of life Chronic stroke patients often experience decreased balance control which negatively affects activities of daily living and their ability to walk independently The most recognized impairments are deficits in motor control and limited mobility Chronic stroke patients may develop spasticity which is the main cause of decreased balance and gait The rate of post-stroke spasticity is 4 - 27 in the 6th week increasing to 426 by the 6th month Electrical stimulation has been used in numerous studies to decrease spasticity
Electrical stimulation has been widely used in stroke rehabilitation including transcutaneous nerve stimulation TENS and neuromuscular electrical stimulation NMES NMES is an effective and conventional therapeutic method for improving motor function in patients with lower extremity paralysis after stroke During NMES current pulses are applied to the muscles or motor nerves through surface electrodes to induce muscle contractions to mimic exercise therapy NMES can help improve muscle strength joint range of motion and promote motor relearning TENS another electrical stimulation is used to relieve pain improve muscle strength and motor function and reduce spasticity through transdermal output pulses The motor recovery mechanism of TENS involves the presynaptic inhibition of the hyperactive stretch reflexes in spastic muscles and decreased co-contraction of the spastic antagonist muscles
Numerous studies have investigated the benefits of TENS or NMES applied to the lower extremities These studies have revealed that both forms of electric stimulation are effective in the recovery of chronic stroke patients
However there is no comparative study on the effect of TENS and NMES applied individually versus their concomitant application The combined application of TENS and NMES may yield better results The aim of this study is to compare the effects of TENS and NMES applied both individually and concomitantly on posture lower extremity motor recovery functional independence motor function recovery and spasticity Hypothesis is that the concomitant application of TENS and NMES will achieve better results than individually application
Electrical stimulation has been widely used in stroke rehabilitation including transcutaneous nerve stimulation TENS and neuromuscular electrical stimulation NMES NMES is an effective and conventional therapeutic method for improving motor function in patients with lower extremity paralysis after stroke During NMES current pulses are applied to the muscles or motor nerves through surface electrodes to induce muscle contractions to mimic exercise therapy NMES can help improve muscle strength joint range of motion and promote motor relearning TENS another electrical stimulation is used to relieve pain improve muscle strength and motor function and reduce spasticity through transdermal output pulses The motor recovery mechanism of TENS involves the presynaptic inhibition of the hyperactive stretch reflexes in spastic muscles and decreased co-contraction of the spastic antagonist muscles
Numerous studies have investigated the benefits of TENS or NMES applied to the lower extremities These studies have revealed that both forms of electric stimulation are effective in the recovery of chronic stroke patients
However there is no comparative study on the effect of TENS and NMES applied individually versus their concomitant application The combined application of TENS and NMES may yield better results The aim of this study is to compare the effects of TENS and NMES applied both individually and concomitantly on posture lower extremity motor recovery functional independence motor function recovery and spasticity Hypothesis is that the concomitant application of TENS and NMES will achieve better results than individually application
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