SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Quality of life by Newcastle Stroke-Specific Quality of Life Measure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group II
Patients who meet the inclusion criteria and who will be treated by surgery.
Intervention: spastic hand sugery (Procedure)
Group I
Patients who meet the inclusion criteria and who will be treated with botulinum toxin (1 injection/4months).
Intervention: Botulinum Toxin A (Drug)
Outcomes
Primary Outcomes
Quality of life by Newcastle Stroke-Specific Quality of Life Measure
Time Frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
is a specific questionnaire to measure the QoL of patients who suffered a stroke. It was developed and validated by Buck et al. It is different from other questionnaires because it includes domains of vision, cognition and communication, and it can used for patients with ischaemic or haemorrhagic stroke and motor aphasia.
Quality of life by 36-Item Short Form Survey Instrument (SF-36)
Time Frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.
Secondary Outcomes
- Functional outcome by Asworth scale(t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation))
- Functional outcome by House hand function scale(t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation))
- Functional outcome by Fugl-mayer scale(t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation))
- Sleep health by SATED scale(t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation))
- Anxiety and depression by HADS scale(t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation))
- Functional outcome by GAS score(t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation))
- Carer Burden by Carer Burden Score(t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation))
- Pain by Visual Analogue Scale(t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation))
- Activity, structure and brain function by MRI(t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation))
Investigators
Pedro Hernández Cortés
MD PhD
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental