StrokeNCT06392633
SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS: RANDOMIZED TRIAL
A study testing spastic hand sugery and Botulinum Toxin A in people with Stroke, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- spastic hand sugery and Botulinum Toxin A
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Granada
Granada, 18016
Pedro Hernández-Cortés, MD PhD, 958240721, phc@ugr.es
About this study
Official title: SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- spastic hand sugery, Botulinum Toxin A
- Keywords
- spastic hand, botulinum toxin, surgery, quality of life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spastic hand sugeryProcedure or surgery
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.
Botulinum Toxin ADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients who meet the inclusion criteria and who will be treated with botulinum toxin (1 injection/4months). Receives: Drug: Botulinum Toxin A |
| Group II | Experimental | Patients who meet the inclusion criteria and who will be treated by surgery. Receives: Procedure: spastic hand sugery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Secondary outcomes (9)
Functional outcome by Asworth scale
It measures the degree of spasticity from 0 to 5. Significant improvement of at least 1 of the 5 joints evaluated (elbow, forearm, wrist, thumb, fingers) will be considered a positive result.
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Functional outcome by House hand function scale
Scale of hand function with 10 degrees of capability
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Functional outcome by Fugl-mayer scale
is the first quantitative evaluative instrument for measuring sensorimotor stroke recovery, based on Twitchell and Brunnstrom's concept of sequential stages of motor return in the hemiplegic stroke patient.
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Functional outcome by GAS score
5-grade scale for the domains hygiene, esthetics and pain. Krasny-Pacini y cols, 2013
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Carer Burden by Carer Burden Score
Scores the caregiver's degree of difficulty for 4 basic activities (nail clipping, palm grooming, armpit grooming, arm dressing) on a 5-point Likert scale.
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Pain by Visual Analogue Scale
A tool used to help a person assess the intensity of certain sensations and feelings, such as pain. The visual analogue pain scale is a straight line where one end means no pain and the other end means the worst pain imaginable. The patient marks a point on the line that matches the amount of pain he or she feels.
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Sleep health by SATED scale
5 questions scale about satisfaction, alertness, timing, efficiency and duration of sleep to know the sleep health of patients. Higher scores (0-10) mean better sleep health.
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Anxiety and depression by HADS scale
Includes 14 items, with scores from 0 to 3 (higher scores reflect greater severity of symptomatology).
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Activity, structure and brain function by MRI
Functional Magnetic Resonance Imaging (fMRI) at rest and with the patient's repeated attempt to extend the elbow and wrist. Anatomical and functional volumes shall be obtained by MRI and fMRI imaging, using a Siemens Prisma 3T functional MRI.
Measured: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jan 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Hernández Cortés, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392633
- Sponsor's protocol ID
- PI20/01574
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hurtado-Olmo P, Hernandez-Cortes P, Gonzalez-Santos A, Simon-Perez C, Olmo-Iruela LD, Catena A. Surgery versus Botulinum Toxin A for Treatment of Post-Stroke Upper-Limb Spasticity: White Matter Changes, Function, and Quality-of-Life-A Randomized Controlled Trial. Neural Plast. 2026;2026(1):e6479640. doi: 10.1155/np/6479640.
PubMed 42839745Hurtado-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.
PubMed 40305524
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS
- ClinicalTrials.gov ID
- NCT06392633
- Acronym / sponsor ID
- PI20/01574
- Conditions
- Stroke
- Keywords
- spastic hand, botulinum toxin, surgery, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía OrientalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Botulinum Toxin APatients who meet the inclusion criteria and who will be treated with botulinum toxin (1 injection/4months). |
| Group II | Experimental | Procedure: spastic hand sugeryPatients who meet the inclusion criteria and who will be treated by surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spastic hand sugeryDeformity 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. | Procedure or surgery | Group II |
| Botulinum Toxin ATreatment 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. | Drug | Group I |
Primary outcome
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.
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.
9 secondary outcomes
Functional outcome by Asworth scale
Time frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Functional outcome by House hand function scale
Time frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Functional outcome by Fugl-mayer scale
Time frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Functional outcome by GAS score
Time frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Carer Burden by Carer Burden Score
Time frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Pain by Visual Analogue Scale
Time frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Sleep health by SATED scale
Time frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Anxiety and depression by HADS scale
Time frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Activity, structure and brain function by MRI
Time frame: t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 42839745Hurtado-Olmo P, Hernandez-Cortes P, Gonzalez-Santos A, Simon-Perez C, Olmo-Iruela LD, Catena A. Surgery versus Botulinum Toxin A for Treatment of Post-Stroke Upper-Limb Spasticity: White Matter Changes, Function, and Quality-of-Life-A Randomized Controlled Trial. Neural Plast. 2026;2026(1):e6479640. doi: 10.1155/np/6479640.
- Derived from this study: PubMed 40305524Hurtado-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spastic hand sugery and Botulinum Toxin A in people with Stroke, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Hernández-Cortés, MD PhD (958240721, phc@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06392633, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.