Clinical trial NCT06392633: SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS: RANDOMIZED TRIAL
Official title: SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: spastic hand
botulinum toxin
surgery
quality of life
Lead sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[surgical treatment (n=22) vs. botulinum toxin (n=22)\] 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.

Eligibility criteria: Inclusion Criteria:

* Patients of legal age, with spasticity in the upper limb due to stroke, with a minimum evolution time of 12 months, who, after being informed orally and in writing of the objectives of the study, sign the informed consent form (themselves or their legal representatives).

Exclusion Criteria:

* Absence of consent, refusal of possible surgical treatment, stroke evolution time of less than 12 months, anaesthetic risk (ASA) class IV or higher, presence of involuntary movements, inability to respond adequately to surveys, deformities that cannot be addressed by surgical treatment or inability to follow up for at least one year.

Primary outcomes:
measure: Quality of life by 36-Item Short Form Survey Instrument (SF-36)
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
measure: Quality of life by Newcastle Stroke-Specific Quality of Life Measure
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Secondary outcomes:
measure: Functional outcome by Asworth scale
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
measure: Functional outcome by House hand function scale
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
measure: Functional outcome by Fugl-mayer scale
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
measure: Functional outcome by GAS score
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
measure: Carer Burden by Carer Burden Score
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
measure: Pain by Visual Analogue Scale
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
measure: Sleep health by SATED scale
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
measure: Anxiety and depression by HADS scale
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
measure: Activity, structure and brain function by MRI
timeFrame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References: