Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079138
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2023-06-25
Brief Title:
Tele-rehabilitation Using TDCS Combined with Exercise in People with Spinal Cord Injury
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Tele-rehabilitation Using Transcranial Direct Current Stimulation Combined with Exercise in People with Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2024-05
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:
This study aims to explore the effect of trans cranial direct current stimulation tDCS combined with self-exercise at home for 1 month training 3 sessionsweek for 4 weeks The outcome assessment including motor function functional activity spasticity through neurological assessment H reflex latency and HM amplitude ratio and quality of life will be assessed before after the intervention and at 1- month follow-up Participant will communicate with physical therapist via video online platform for every sessions 12 sessions
Detailed Description:
Spinal cord injury SCI can cause paralysis and functional disability resulting in changes in strength and sensation Rehabilitation is important for regaining independence but short hospital stays and limited access to specialized clinics pose challenges Telerehabilitation offers a solution by providing remote rehabilitation services
Physical exercise and functional training are important for improving functional activity and endurance after SCI Telerehabilitation has shown significant improvements in functional activity However the most effective gains occur within the first year after the injury and rehabilitation training alone may not achieve full recovery Impairments below the injury level can lead to changes in brain organization Combining training with a top-down approach may promote motor recovery after SCI
Transcranial direct current stimulation tDCS is a non-invasive brain stimulation technique used in neurorehabilitation It can modulate neural activity in the primary motor cortex at both cortical and spinal levels and induce synaptic plasticity Studies have shown that adjusting the intensity or duration of tDCS can enhance its effectiveness with anodal stimulation increasing cortical excitability and cathodal stimulation decreasing it Home-based tDCS is a safe accessible and convenient alternative to hospital-based tDCS Previous research has suggested a positive trend for combining anodal tDCS with rehabilitation training in individuals with incomplete spinal cord injury Strong arm endurance is crucial for individuals with complete SCI who require independent transfers and wheelchair use Studies in healthy adults have demonstrated that tDCS combined with exercise can improve upper arm endurance However there is currently no research on the effects of tDCS combined with rehabilitation in improving functional skills for individuals with complete SCI especially when applied through home-based tDCS with telerehabilitation
In the early stages of spinal shock following a severe spinal cord injury SCI the H-reflex a reflex measure of spinal cord excitability is typically absent or significantly reduced below the injury site The degree and duration of this reflex suppression indicate the severity of the injury This loss of reflex activity is thought to result from decreased excitability of motoneurons due to the sudden loss of input from the brain However the H-reflex gradually starts to recover after the initial spinal shock phase In patients with chronic complete spinal cord lesions an increased H-reflex amplitude in the soleus muscle suggests heightened central synaptic excitability which may contribute to the development of hyperreflexia after SCI Recent research has shown that anodal tDCS can decrease the HM ratio the ratio of H-reflex to M-response and H-reflex latency leading to improved spasticity in patients with neurological conditions
This study aims to investigate the impact of combining tDCS with self-exercise at home over a one-month training period The training will involve three sessions per week for four weeks The assessment will include measures of motor function functional activity spasticity evaluated through neurological assessment of H-reflex latency and HM amplitude ratio and quality of life The participants will interact with a physical therapist through a video online platform for each of the 12 sessions Assessments will be conducted before and after the intervention as well as at a one-month follow-up
Physical exercise and functional training are important for improving functional activity and endurance after SCI Telerehabilitation has shown significant improvements in functional activity However the most effective gains occur within the first year after the injury and rehabilitation training alone may not achieve full recovery Impairments below the injury level can lead to changes in brain organization Combining training with a top-down approach may promote motor recovery after SCI
Transcranial direct current stimulation tDCS is a non-invasive brain stimulation technique used in neurorehabilitation It can modulate neural activity in the primary motor cortex at both cortical and spinal levels and induce synaptic plasticity Studies have shown that adjusting the intensity or duration of tDCS can enhance its effectiveness with anodal stimulation increasing cortical excitability and cathodal stimulation decreasing it Home-based tDCS is a safe accessible and convenient alternative to hospital-based tDCS Previous research has suggested a positive trend for combining anodal tDCS with rehabilitation training in individuals with incomplete spinal cord injury Strong arm endurance is crucial for individuals with complete SCI who require independent transfers and wheelchair use Studies in healthy adults have demonstrated that tDCS combined with exercise can improve upper arm endurance However there is currently no research on the effects of tDCS combined with rehabilitation in improving functional skills for individuals with complete SCI especially when applied through home-based tDCS with telerehabilitation
In the early stages of spinal shock following a severe spinal cord injury SCI the H-reflex a reflex measure of spinal cord excitability is typically absent or significantly reduced below the injury site The degree and duration of this reflex suppression indicate the severity of the injury This loss of reflex activity is thought to result from decreased excitability of motoneurons due to the sudden loss of input from the brain However the H-reflex gradually starts to recover after the initial spinal shock phase In patients with chronic complete spinal cord lesions an increased H-reflex amplitude in the soleus muscle suggests heightened central synaptic excitability which may contribute to the development of hyperreflexia after SCI Recent research has shown that anodal tDCS can decrease the HM ratio the ratio of H-reflex to M-response and H-reflex latency leading to improved spasticity in patients with neurological conditions
This study aims to investigate the impact of combining tDCS with self-exercise at home over a one-month training period The training will involve three sessions per week for four weeks The assessment will include measures of motor function functional activity spasticity evaluated through neurological assessment of H-reflex latency and HM amplitude ratio and quality of life The participants will interact with a physical therapist through a video online platform for each of the 12 sessions Assessments will be conducted before and after the intervention as well as at a one-month follow-up
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