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

NCT ID: NCT06392633

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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spastic hand botulinum toxin surgery quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I

Patients who meet the inclusion criteria and who will be treated with botulinum toxin (1 injection/4months).

Group Type ACTIVE_COMPARATOR

Botulinum Toxin A

Intervention Type DRUG

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.

Group II

Patients who meet the inclusion criteria and who will be treated by surgery.

Group Type EXPERIMENTAL

spastic hand sugery

Intervention Type PROCEDURE

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.

Interventions

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spastic 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.

Intervention Type PROCEDURE

Botulinum 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

OTHER

Sponsor Role lead

Responsible Party

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Pedro Hernández Cortés

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Granada

Granada, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Pedro Hernández-Cortés, MD PhD

Role: CONTACT

Phone: 958240721

Email: [email protected]

Facility Contacts

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Pedro Hernández-Cortés, MD PhD

Role: primary

References

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Hurtado-Olmo P, Gonzalez-Santos A, Iruela LDO, Castro-Ropero B, Zuniga-Gomez L, Bueno-Garcia AI, Guijosa-Campos P, Gomez-Pozo B, Hita-Contreras F, Hernandez-Cortes P. Impact of surgery on rehabilitation care and quality of life perceived by patient with post-stroke upper limb spasticity: Study protocol for a randomized controlled trial. PLoS One. 2025 Apr 30;20(4):e0322588. doi: 10.1371/journal.pone.0322588. eCollection 2025.

Reference Type DERIVED
PMID: 40305524 (View on PubMed)

Other Identifiers

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PI20/01574

Identifier Type: -

Identifier Source: org_study_id