Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547684
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Focused Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy fESWT on triceps surae spasticity in stroke patients according to the number of sessions applied
Hypothesis 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT
Hypothesis 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT
Detailed Description:
Spasticity is a common complication as a consequence of suffering a stroke and one of the most important causes of disability in this pathology
Global data estimate that 12 million people world-wide suffer from spasticity of the upper or lower limb Equinus foot is the most common pattern of the lower extremities
Previous studies have reported that extracorporeal shock wave therapy ESWT is a safe and noninvasive alternative treatment for spasticity
Although the authors have shown a beneficial clinical effect of the ESWT outcomes and duration of effect varied across studies
This is a prospective randomized controlled trial 60 stroke patients with spastic equinus foot post stroke will enroll in this study
The participants will be randomly divided into two groups The first group control group will receive 1 session of fESWT while the second group experimental group will receive 3 sessions of fESWT once a week for 3 consecutive weeks
Therapy will be administered directly to the muscle bellies of the gastrocnemius medial and lateral and soleus The muscle belly will be located by ultrasonography
The primary outcome is modified Ashworth scale Secondary outcomes are passive range of ankle motion mobility and balance test spasm frequency scale and quality of life scales
Participants will be evaluated by the same researcher before the first shock wave therapy and after the last session of fESWT will be done periodic revisions on weeks 1 4 8 12 20 24 36 and 48 Adverse events will be monitored during the study
Global data estimate that 12 million people world-wide suffer from spasticity of the upper or lower limb Equinus foot is the most common pattern of the lower extremities
Previous studies have reported that extracorporeal shock wave therapy ESWT is a safe and noninvasive alternative treatment for spasticity
Although the authors have shown a beneficial clinical effect of the ESWT outcomes and duration of effect varied across studies
This is a prospective randomized controlled trial 60 stroke patients with spastic equinus foot post stroke will enroll in this study
The participants will be randomly divided into two groups The first group control group will receive 1 session of fESWT while the second group experimental group will receive 3 sessions of fESWT once a week for 3 consecutive weeks
Therapy will be administered directly to the muscle bellies of the gastrocnemius medial and lateral and soleus The muscle belly will be located by ultrasonography
The primary outcome is modified Ashworth scale Secondary outcomes are passive range of ankle motion mobility and balance test spasm frequency scale and quality of life scales
Participants will be evaluated by the same researcher before the first shock wave therapy and after the last session of fESWT will be done periodic revisions on weeks 1 4 8 12 20 24 36 and 48 Adverse events will be monitored during the study
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