Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392633
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Brief Title:
SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS RANDOMIZED TRIAL
Sponsor:
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Organization:
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Study Overview
Official Title:
SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS
Status:
RECRUITING
Status Verified Date:
2024-04
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:
We present a research project in the form of a controlled clinical trial with the aim of analyzing and demonstrating whether the surgical treatment of upper limb spasticity is an effective and efficient measure to improve dependence and quality of life perceived by patients with sequelae of stroke and therefore should be included in the therapeutic protocols in which it is not usually contemplated as a complement or alternative to traditional treatment with botulinum toxin rehabilitation and occupational therapy
Detailed Description:
Cerebrovascular accident CVA or stroke is the leading cause of permanent disability in adulthood and many patients require lifelong medical treatment and assistance from other people for the development of their daily activities The repercussion in the family professional labor and social fields is enormous producing a very important economic expense The usual treatment of spastic upper limb secondary to stroke is rehabilitation occupational therapy and periodic injection of botulinum toxin and surgical correction is not usually considered A two-arm Randomized Clinical Trial surgical treatment n22 vs botulinum toxin n22 is proposed with the aim of investigating the efficacy and efficiency of surgery for upper limb spasticity with respect to treatment with botulinum toxin in patients with established spastic sequelae after stroke
We will evaluate the effect on functionality and hygienic changes the impact on quality of life sleep quality anxiety and depression as well as on brain activity by Functional Magnetic Resonance Imaging at baseline and at 6 and 12 months follow-up The health and care costs of the established groups of patients will also be evaluated This research is framed in the context of chronic diseases aging and patients with functional and mobility difficulties The results of this work are expected to have a great impact due to the high prevalence of the disease the severe disability it causes and the number of patients who would benefit in addition to the savings in healthcare resources The incorporation of surgery into stroke care would change the current treatment paradigm favoring the formation of multidisciplinary teams for the treatment of the disease
We will evaluate the effect on functionality and hygienic changes the impact on quality of life sleep quality anxiety and depression as well as on brain activity by Functional Magnetic Resonance Imaging at baseline and at 6 and 12 months follow-up The health and care costs of the established groups of patients will also be evaluated This research is framed in the context of chronic diseases aging and patients with functional and mobility difficulties The results of this work are expected to have a great impact due to the high prevalence of the disease the severe disability it causes and the number of patients who would benefit in addition to the savings in healthcare resources The incorporation of surgery into stroke care would change the current treatment paradigm favoring the formation of multidisciplinary teams for the treatment of the disease
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