RecruitingNot ApplicableNCT06392633

SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS: RANDOMIZED TRIAL

SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS

Sponsor

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Enrollment

44 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Stroke

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

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 Criteria1

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.

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Interventions

PROCEDUREspastic hand sugery

Deformity correction can be performed with single event multilevel surgery, using a combination of soft tissue releases and lengthening, tendon transfers and joint stabilization procedures. In addition, selective and supraselective neurectomies can also be performed.

DRUGBotulinum Toxin A

Treatment consists of periodic injections of the toxin into the spastic muscles. It causes reversible chemical denervation by preventing the release of acetylcholine vesicles at the neuromuscular junctions of the affected muscles.