Viewing Study NCT06562530



Ignite Creation Date: 2024-10-26 @ 3:38 PM
Last Modification Date: 2024-10-26 @ 3:38 PM
Study NCT ID: NCT06562530
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: None
First Post: 2024-08-14

Brief Title: Effect of High Tone Power Therapy on Spasticity and Gait Kinematics in Stroke Patients
Sponsor: None
Organization: None

Study Overview

Official Title: High Tone Power Therapy Versus Transcutaneous Electrical Nerve Stimulation on Spasticity and Selected Kinematic Gait Parameters in Stroke Patients
Status: ACTIVE_NOT_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: This study aims to compare between High tone power therapy modulated frequency current and Transcutaneous electrical nerve stimulation fixed frequency current on spasticity and selected kinematic gait parameters in stroke patients
Detailed Description: Stroke is a neurological deficit attributed to an acute focal injury of the central nervous system CNS by a vascular cause Stroke is one of the leading causes of disability and mortality in the globe stroke occurs when blood flow to the brain is restricted due to a blocked or ruptured artery the cerebral energy supply is interrupted resulting in tissue destruction and widespread neuronal cognitive impairments and psychological morbidity

Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually Stroke has been described as a major source of both mortality and global disability Approximately 795000 people experience stroke annually and 60 or 465000 of them need rehabilitation

Spasticity is a symptom of stroke brain and spinal cord damage multiple sclerosis cerebral palsy and other neurological illnesses that cause paralysis The most common spastic pattern in the lower limbs is adduction and extension of the knee with an Equinovarus foot This impacts gait patterns and daily functioning activities

Treatment modalities for the management of spasticity include Stretching splinting Neuromuscular electrical stimulation NMES extracorporeal shock wave therapy transcranial and spinal cord magnetic stimulation Surgical treatment neurectomy rhizotomy and myelotomy also many drugs used for treating spasticity oral drugs like Baclofen Tizanidine and injectable medications like Phenolalcohol and Botulinum 2 toxin

Transcutaneous electrical nerve stimulation TENS stimulates large diameter mechano-sensitive nerve fibers in the skin its a non-invasive treatment that has been reported to affect pain control and sensory stimulation which is commonly used in the treatment of chronic and acute pain with possible mechanisms of action including segmental inhibition the release of endogenous opioids counter-irritation nerve conduction block increase muscle power and movement function

High-tone power therapy HTT is a unique characteristic of electrotherapy It uses intermediate frequency metal-compatible alternating current whose frequency oscillates between approximately 4000 Hz and 33000 Hz and intensity is adjusted unlike traditional electrotherapies as transcutaneous electrical nerve stimulation TENS Its main effects are introducing energy into the body to activate cells producing an oscillation or vibration in the cells and tissues to promote metabolism scattering the mediators of pain and inflammation leading to pain relief and normalizing cell metabolism and nerve regeneration

The effective management of spasticity continues to pose challenges to physiotherapy management there appears to be a dearth of adequate information on high tone power therapy in the management of spasticity There are several physiotherapy approaches for managing spasticity but there is a lack of evidence to show which is most effective

Statement of the problem

This study will answer the following question Is there any difference between the effect of high-tone power therapy modulated frequency current versus transcutaneous electrical nerve stimulation fixed frequency current on spasticity and selected kinematic gait parameters in stroke patients

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