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

NCT06392633 | Recruiting

• 1 other identifier: PI20/01574
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

spastic hand; botulinum toxin; surgery; quality of life

Outcome Measures

Primary Outcomes (2)

• Quality of life by 36-Item Short Form Survey Instrument (SF-36)

  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.

  t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)

• Quality of life by Newcastle Stroke-Specific Quality of Life Measure

  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.

  t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)

Secondary Outcomes (9)

• 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)

• 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)

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Drug: Botulinum Toxin A

Group II

EXPERIMENTAL

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

Procedure: spastic hand sugery

Interventions

spastic hand sugery 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.

Group II

Botulinum Toxin A 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 I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: lead

Study Sites (1)

University of Granada

Granada, 18016, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 40305524 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Pedro Hernández-Cortés, MD PhD

CONTACT

958240721; phc@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: January 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

ES (1)